CHIA PERCPASSER 214101Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10886705003433), received between Jul 21, 2018 and May 7, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (17 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, IT WAS OBSERVED THAT THE CHIA PERCPASSER SUTURE PASSER 5 PACK DEVICE WAS BROKEN INSIDE THE PATIENT'S INCISION. IT WAS REPORTED THAT THE BROKEN PARTS WAS ABOUT 6CM AND THE DEVICE WAS SUBSEQUENTLY REMOVED IN A TIMELY MANNER. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21975552 ↗
• MalfunctionApr 1, 2025Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, IT WAS OBSERVED THAT THE CHIA PERCPASSER SUTURE PASSER DEVICE SUTURE SHUTTLE TIP WAS BROKEN AND DID NOT PASS SUTURE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21739480 ↗
• MalfunctionNov 18, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE CHIA WIRE WITHIN THE IDEAL SUTRE SHUTLE STRGHT CRESCENT -G BROKE AT THE TIP OF THE KITE. IT WAS REPORTED THAT THE BROKEN CHIA WAS REPLACED WITH ANOTHER CHIA WHICH ALSO BROKE AT THE KITE AREA OF THE CHIA PERCPASSER SUTURE PASSER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 10-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20708112 ↗
• MalfunctionMay 22, 2023Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, A CHIA PERCPASSER SUTURE PASSER AND A 4.9MM HEALX ADV SP PEEK ANCHOR WERE USED TOGETHER. ACCORDING TO THE REPORT, THE ANCHOR KITE WAS PULLED PARTIALLY UP THE ANCHOR BY THE SUTURE PASSER BUT THE KITE BROKE, AND THEREFORE, THE SUTURE PASSER FAILED TO BRING THE SUTURE THROUGH THE ANCHOR. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16978619 ↗
• MalfunctionOct 19, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN CZECH REPUBLIC THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE CHIA PERCPASSER SUTURE PASSER DEVICE CURLED AND TORE AT THE TIP AFTER THE FIRST STRETCHING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632318 ↗
• MalfunctionOct 19, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN CZECH REPUBLIC THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE CHIA PERCPASSER SUTURE PASSER DEVICE CURLED AND TORE AT THE TIP AFTER THE FIRST STRETCHING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632310 ↗
• MalfunctionOct 19, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN CZECH REPUBLIC THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE CHIA PERCPASSER SUTURE PASSER DEVICE CURLED AND TORE AT THE TIP AFTER THE FIRST STRETCHING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632299 ↗
• MalfunctionOct 19, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN CZECH REPUBLIC THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE CHIA PERCPASSER SUTURE PASSER DEVICE CURLED AND TORE AT THE TIP AFTER THE FIRST STRETCHING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632294 ↗
• MalfunctionOct 19, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN CZECH REPUBLIC THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE CHIA PERCPASSER SUTURE PASSER DEVICE CURLED AND TORE AT THE TIP AFTER THE FIRST STRETCHING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632286 ↗
• MalfunctionOct 19, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN CZECH REPUBLIC THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022 , IT WAS OBSERVED THAT THE CHIA PERCPASSER SUTURE PASSER DEVICE CURLED AND TORE AT THE TIP AFTER THE FIRST STRETCHING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632280 ↗
• MalfunctionOct 19, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN CZECH REPUBLIC THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE CHIA PERCPASSER SUTURE PASSER DEVICE CURLED AND TORE AT THE TIP AFTER THE FIRST STRETCHING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632277 ↗
• MalfunctionOct 19, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN CZECH REPUBLIC THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE CHIA PERCPASSER SUTURE PASSER DEVICE CURLED AND TORE AT THE TIP AFTER THE FIRST STRETCHING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632271 ↗
• MalfunctionOct 19, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN CZECH REPUBLIC THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE CHIA PERCPASSER SUTURE PASSER DEVICE CURLED AND TORE AT THE TIP AFTER THE FIRST STRETCHING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632246 ↗
• MalfunctionOct 19, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN CZECH REPUBLIC THAT DURING AN UNKNOWN SURGERY ON 9/1/2022, IT WAS OBSERVED THAT THE CHIA PERCPASSER SUTURE PASSER DEVICE CURLED AND TORE AT THE TIP AFTER THE FIRST STRETCHING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632241 ↗
• MalfunctionApr 20, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SUTURE/ NEEDLE PASSER DEVICE BROKE WHILE LOADING THE SUTURE DEVICE, PULLING IT BACK INTO THE TIP AND OUT OF THE SHOULDER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11694480 ↗
• MalfunctionDec 9, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT DURING AN ARTHROSCOPIC SHOULDER ROTATOR CUFF REPAIR THE CHIA PERCPASSER SUTURE PASSER 5 PACK WAS OPEN FROM AN STERILE PACKAGE AND AS THE SURGEON PASS THE WIRE AND LOADED WITH THE ORTHOCORD FOR THE FIRST TIME, IT SNAPPED ON THE FIRST PULL. THE SURGEON WAS NOT HAPPY AT ALL AS THE CHIA PERCPASSER SUTURE PASSER 5 PACK WAS BRAND NEW AND IT SNAPPED ON THE FIRST SUTURE PASSING. NO INDICATION WAS MADE. BUT IN ORDER TO MAKE HIM HAPPY AND NOT WASTE ANY TIME, THE REP OFFERED TO OPEN A NEW CHIA PERCPASSER SUTURE PASSER 5 PACK AND ASSURE THAT A PRODUCT COMPLAINT WAS GOING TO BE MADE. SINCE THIS WAS THE FIRST TIME IT SNAPPED ON THE FIRST SUTURE PASSING. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS MADE. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE SURGEON WAS NOT HAPPY AS HE RECKONS THIS CHIAWIRE SHOULD WORK AS MUCH TIME AS POSSIBLE AS IT IS MADE FROM STEEL. HOWEVER MOST TIME THE WIRE WILL SNAPPED SOMETIME IN MID SURGERY (MAYBE DUE TO THE STRENGTH OF HIM PULLING IT AS WELL SINCE HE USUALLY PASSED AROUND MIN 4X TO MAX OF 12X). SO HE DOES NOT HAVE AN IMPRESSION THIS CHIA

  Patient problems: Not Applicable

  MAUDE report 9438983 ↗
• MalfunctionFeb 4, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED BY THE AFFILIATE IN (B)(4) THAT PRIOR TO AN UNKNOWN PROCEDURE THE DEVICE'S PACKAGING WAS NOT SEALED ON ONE SIDE, MAKING IT NON-STERILE. THE OTHER DEVICES IN THE BOX WERE PROPERLY SEALED. THE AFFILIATE REPORTED NO PATIENT CONSEQUENCE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGERY OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8302028 ↗
• MalfunctionJul 21, 2018Break; Break

  THE SURGEON WAS DOING AN ARTHROSCOPIC LABRAL REPAIR. HE ATTEMPTED TO PASS/SHUTTLE SUTURE THROUGH THE TISSUE AND THE TOP OF THE CHIA KITE/LOOP FROM THE IDEAL PASSER BROKE OPEN. HE THEN OPENED A NEW CHIA WIRE AND ATTEMPTED ANOTHER PASS. IT TOO BROKE AT THE TOP OF THE KITE/LOOP. HE USED HIS OLD MANUAL INSTRUMENTS AND A PDS SUTURE LOOP. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-54120.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7708707 ↗