Arthrex® AR-13226TSRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867198609), received between Feb 14, 2022 and Jan 20, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026Break

  ON 05-JAN-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-13226TS BB-TAK TIP BROKE WHILE FIXING THE PLATE. THE BROKEN TIP COULD NOT BE RETRIEVED. THIS OCCURRED DURING USE IN A ORIF CASE WITH NO PATIENT EFFECT. NO DELAY IN CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24114821 ↗
• MalfunctionNov 5, 2025Break; Break

  ON 10/23/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-13226TS THREADED BBTAK WAS USED TO TEMPORARILY FIXATE THE PLATE IN DISTAL FIBULA FRACTURE REPAIR. WHEN ATTEMPTING TO REMOVE IT, THE SURGEON NOTICED THAT THE THREADS HAD BROKEN AND THAT A FRAGMENT HAD REMAINED INSIDE THE BODY. THIS OCCURRED DURING USE IN A CASE. AS REMOVAL WOULD BE DIFFICULT, THE FRAGMENT WAS LEFT IN PLACE AND THE SURGERY WAS COMPLETED. NO ADDITIONAL PRODUCTS WERE REQUIRED TO COMPLETE THE SURGERY. THE PLATE USED WAS AR-9963APLL-06S (LOT NUMBER UNKNOWN). NO PHOTO IS AVAILABLE. TYPE OF THE SURGERY WAS DISTAL FIBULA FRACTURE REPAIR. NO SIGNIFICANT SURGERY DELAY REPORTED. NO ADDITIONAL ANESTHESIA ADMINISTERED TO THE PATIENT. NO INFORMATION ABOUT AN INSTRUMENT USED TO PREPARE/TAP THE BONE SOCKET FOR INSERTION OF THE IMPLANT. BONE QUALITY OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 23477164 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED DURING THE LAPIDUS ARTHRODESIS WITH A PLANTAR LAPIDUS PLATE THAT THE FRONT PART OF THE INSTRUMENT, WHERE THE THREAD IS LOCATED, BROKE OFF WHEN SCREWING IT IN TO FIX THE PLATE. THE BROKEN PART COULD BE REMOVED WITHOUT FURTHER DAMAGE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23295438 ↗
• MalfunctionJan 23, 2025Break; Break

  ON 12/23/2024 IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-13226TS BB-TAK. PIN BROKE AND REMAINED IN BONE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 21217731 ↗
• MalfunctionAug 23, 2024Break; Break

  IT WAS REPORTED THAT DURING A MTPJ REVISION (USING 2MM LOCKING OPENING WEDGE PLATE) THE BB-TAK BROKE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20045696 ↗
• MalfunctionDec 2, 2022Break

  IT WAS REPORTED THAT DURING A LISFRANC PLATING SURGERY PARTS OF THE DEVICE SHEARED OFF DURING USE. ALL PARTS WERE RETRIEVED OUT OF THE PATIENT. ACCORDING TO THE SURGEON THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15905615 ↗
• MalfunctionJun 20, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-13226TS BB-TAK BROKE. THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE PATIENT. PER FACILITY: "IT WAS USED TO FIX THE FIBULA PLATE. THE AREA BETWEEN THE HEAD AND SHAFT WAS BROKEN OFF."

  Patient problems: Insufficient Information

  MAUDE report 14744816 ↗
• MalfunctionFeb 14, 2022Break

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-13226TS TREADED BB-TAK BROKE DURING A SURGERY. THE THREADED PART BROKE WHILE INSERTING INTO THE BONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY HOWEVER, THE BROKEN PIECE WAS NOT RETRIEVED FROM THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 13528460 ↗