Arthrex® AR-8730-42HRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867303331), received between Oct 23, 2019 and Jan 11, 2021 — classified as 7 injuries.

The most frequently reported specific device problem is “Break” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2021Break

  IT WAS REPORTED THAT DURING A (B)(6) 2020 TMT FUSION/LAPIDUS PROCEDURE THE SURGEON WAS IMPLANTING A AR-8730-42H, COMPRESSION FT SCREW, AND AFTER APPROXIMATELY 30MM WAS INSERTED THE SCREW BROKE. THE 12MM PIECE WAS RETRIEVED BUT THE 30MM THAT WAS INSERTED WAS LEFT IN. THE SCREW WAS CROSSING THE FUSION SITE. SALES REPRESENTATIVE STATES SURGEON WOULD HAVE LIKED MORE COMPRESSION FROM THE SCREW BE DID NOT THINK TAKING IT OUT WAS THE BEST OPTION. SURGEON PLATED OVER THE SITE TO STABILIZE. NO ADDITIONAL OR LARGER INCISION WERE NEEDED. THE ORIGINAL PLAN WAS TO USE A HEADLESS SCREW ACROSS THE FUSION SITE FOR COMPRESSION AND A PLAT TO STABILIZE. THE TECHNIQUE REMAINED THE SAME BUT WITH NOT AS MUCH COMPRESSION AS WAS ORIGINALLY PLANNED. RETRIEVED PIECE WAS DISCARDED BY THE SCRUB TECH.

  Patient problems: Insufficient Information

  MAUDE report 11146664 ↗
• InjuryOct 12, 2020Break

  IT WAS REPORTED DURING A BILATERAL HALLUX VALGUS PROCEDURE THE AR-8730-42H MINI COMPRESSION FT SCREW WAS IMPLANTED USING SCREWDRIVER ON POWER. UPON INSERTION THE SCREW BROKE ABOUT 15 THREADS BELOW DRIVER. BROKEN PIECE OF SCREW WAS RETRIEVED BUT THE REST WAS LEFT IMPLANTED. OSTEOTOMY SITE WAS STABLE WITH BROKEN MINI SCREW AND A 4.0 STANDARD SCREW PLACED PARALLEL TO IT. THE SECOND BUNION WAS TREATED WITH TWO 4.0 STANDARD SCREWS.

  Patient problems: Foreign Body In Patient

  MAUDE report 10666977 ↗
• InjuryAug 24, 2020Break

  IT WAS REPORTED THAT DURING AN MIS BUNION PROCEDURE (B)(6) 2020. WHILE IMPLANTING A SECOND SCREW THE COMPRESSION FT SCREW (AR-8730-42H) BROKE ABOUT MID-SHAFT. REPORTER STATES CORRECT DRILLING WAS PERFORMED AND THE PATIENT BONE QUALITY WAS AVERAGE. ALL PIECES WERE FULLY RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED USING A LAPIDUS PLATE. NO ADDITIONAL UNPLANNED INCISIONS WERE NEEDED TO REMOVE THE SCREW PIECES HOWEVER A BIGGER INCISION WAS NEEDED TO PUT THE LAPIDUS PLATE ON. A PROFILE DRILL FOR 3.5 SCREW AND A 2.7 DRILL BIT HAD BEEN USED TO PREP THE BONE SOCKET. A T-10 CANNULATED HEXALOBE DRIVER WITH A RATCHETING HANDLE WAS USED TO IMPLANT THE SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10443262 ↗
• InjuryFeb 25, 2020Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING A CHEVRON OSTEOTOMY PROCEDURE AS THE SURGEON PUT IN THE FIRST 3.5 X 42 MM MINI SCREW, THE SCREW BROKE COMPLETELY IN HALF. THE LATTER HALF OF THE SCREW CAME OUT WITH THE DRIVER BUT THE SURGEON HAD TO MAKE A BIGGER INCISION FROM THEIR PREVIOUS MIS INCISION TO THEN USE A RONJOUR TO GET OUT THE FIRST HALF OF SCREW THAT WAS STILL IN THE BONE. THE SURGEON THEN USED A NEW GUIDE WIRE AND USED A 40MM SCREW TO FIX THE CORRECTION. THEN THE SURGEON WENT TO USE ANOTHER 42MM SCREW AS A SECOND POINT OF FIXATION AND THIS SCREW WAS STRIPPED AND BROKE OFF APPROX 1/4 OF THE LENGTH. HOWEVER, THAT SCREW WAS HOLDING UP WELL ACROSS THE OSTEOTOMY AND GAVE THE BONE A GOOD HOLD SO THE SURGEON CHOSE TO KEEP IT IN SINCE IT WAS HOLDING WELL. IN CONCLUSION, THE FIRST SCREW USED (3.5 X 42) COMPLETELY BROKE IN HALF. THE SECOND SCREW (3.5 X 40) WENT IN FINE. THE THIRD SCREW (3.5 X 42) HAD THE END BREAK OFF, APPROX 1/4 OF IT, BUT HELD UP IN THE BONE AND STAYED IN. REQUEST SENT TO REP FOR PART AND LOT NUMBERS OF COMPLAINT DEVICES. ADDITIONAL INFORMATION RECEIVED ON 02/12/2020: THE REP PROVIDED THE PART AND LOT NUMBERS OF THE TWO BROKEN SCREWS (AR-8730-42H / LOT: 10448214 & LOT: 10504055).

  Patient problems: No Code Available

  MAUDE report 9751238 ↗
• InjuryFeb 25, 2020Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING A CHEVRON OSTEOTOMY PROCEDURE AS THE SURGEON PUT IN THE FIRST 3.5 X 42 MM MINI SCREW, THE SCREW BROKE COMPLETELY IN HALF. THE LATTER HALF OF THE SCREW CAME OUT WITH THE DRIVER BUT THE SURGEON HAD TO MAKE A BIGGER INCISION FROM THEIR PREVIOUS MIS INCISION TO THEN USE A RONJOUR TO GET OUT THE FIRST HALF OF SCREW THAT WAS STILL IN THE BONE. THE SURGEON THEN USED A NEW GUIDE WIRE AND USED A 40MM SCREW TO FIX THE CORRECTION. THEN THE SURGEON WENT TO USE ANOTHER 42MM SCREW AS A SECOND POINT OF FIXATION AND THIS SCREW WAS STRIPPED AND BROKE OFF APPROX 1/4 OF THE LENGTH. HOWEVER, THAT SCREW WAS HOLDING UP WELL ACROSS THE OSTEOTOMY AND GAVE THE BONE A GOOD HOLD SO THE SURGEON CHOSE TO KEEP IT IN SINCE IT WAS HOLDING WELL. IN CONCLUSION, THE FIRST SCREW USED (3.5 X 42) COMPLETELY BROKE IN HALF. THE SECOND SCREW (3.5 X 40) WENT IN FINE. THE THIRD SCREW (3.5 X 42) HAD THE END BREAK OFF, APPROX 1/4 OF IT, BUT HELD UP IN THE BONE AND STAYED IN. REQUEST SENT TO REP FOR PART AND LOT NUMBERS OF COMPLAINT DEVICES. ADDITIONAL INFORMATION RECEIVED ON 02/12/2020: THE REP PROVIDED THE PART AND LOT NUMBERS OF THE TWO BROKEN SCREWS (AR-8730-42H / LOT: 10448214 & LOT: 10504055).

  Patient problems: No Code Available

  MAUDE report 9751229 ↗
• InjuryNov 14, 2019Break

  IT WAS REPORTED BY THE SALES REP, THAT DURING AN IPJ FUSION PROCEDURE, THE SURGEON PREPPED THE INSERTION SOCKET USING THE PROFILE DRILL, UPON INSERTION OF THE AR-8730-42H, COMPRESSION SCREW THE SCREW SNAPPED APPROXIMATELY 1/3 THE LENGTH OF THE SCREW. THE SURGEON REMOVED ALL PIECES CAUSING A DELAY IN CASE OF 1 1/2 HOURS. THE CASE WAS COMPLETED USING A DIFFERENT AR-8730-42H, COMPRESSION SCREW. ADDITIONAL INFORMATION 10/24/2019: THE SALES REP HAS STATED THAT THE ANESTHESIOLOGIST HAD TO USE ADDITIONAL ANESTHESIA DUE THE DELAY IN CASE. WHERE THE SCREW SNAPPED IT WAS FLUSH WITH THE SKIN AND THE SURGEON WAS FORCED TO CUT A WIDER AND DEEPER INCISION IN ORDER TO ACCESS THE SCREW HALF TO REMOVE IT FROM THE PATIENT'S TOE. THE SURGEON ENDED UP USING A LARGER DIAMETER SCREW (4.0 MM HEADLESS FT SCREW, AR-8740-42H) TO COMPLETE THE PROCEDURE. SURGEON DID NOT WANT TO USE THE SAME SIZE SCREW AGAIN IN CASE IT WOULD SNAP IN HALF AGAIN. THE PATIENT IS A SMALL FEMALE WITH PETITE BONE STRUCTURE.

  Patient problems: Tissue Damage

  MAUDE report 9324361 ↗
• InjuryOct 23, 2019Break

  IT WAS REPORTED THAT DURING A MIS BUNION PROCEDURE, THE 3.5MM MINI COMPRESSION SCREW, AR-8730-42H, BROKE FLUSH AT THE MEDIAL CORTEX DURING INSERTION. THE SURGEON LEFT THE SCREW IN AND INSERTED A 1.1 K-WIRE FOR POST-OP PROTOCOL. NO FURTHER DETAILS, ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED (B)(6) 2019- TO PREP THE BONE, THE SURGEON CHOSE THE 3.5 HEADLESS FT K-WIRE, MEASURED, USED A STRAIGHT DRILL (NO PROFILE DRILL) AND THEN IMPLANTED THE SCREW WITH A DRIVER. DURING INSERTION, THE SCREW SNAPPED AT THE MEDIAL CORTEX. THE HEAD OF THE SCREW REMAINED CANNULATED ON THE K-WIRE AND WAS ABLE TO BE REMOVED ONTO THE STERILE FIELD. THE PATIENT'S BONE WAS OF MEDIUM QUALITY. THE K-WIRE POKING OUT OF THE FOOT IS A NORMAL POST OP PROTOCOL DEPENDING ON THE PROCEDURE, BUT IT WASN¿T THE INITIAL PLAN FOR THIS MIS BUNION PROCEDURE. THE K-WIRE WILL STAY IN THE FOOT FOR APPROXIMATELY 6-8 WEEKS.

  Patient problems: No Code Available

  MAUDE report 9225785 ↗