MAUDE Adverse Event Report: SYNTHES GMBH RETENT PIN SCRDRIVER QC HEX 12/SHT/XL25; SCREWDRIVER

Catalog Number	03.045.008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that retent pin scrdriver qc hex 12/sht/xl25, t15 cann strdrv scrwdrvr sft slf-retain, 2.7mm cann drill bit qc/145mm, scrdriver-hex-small w/hold-sleeve, monobloc flexible reamer 14 - std - dd, monobloc flex reamer 14.5 - long - dd, drive shaft for ria 2 520mm, t25 sddrive screwdriver shaft 241mm, and torque limiting attachment 4nm for ao reaming coupler were reported as damaged during post-operative inspection.The failures included broken tips, stripped features, rust inside cannulas, and non-functioning torque limiter.There was no patient involvement or harm, and no procedure was associated with the event.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: added: d9, d10 the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: corrected: g1 manufacturer site.H3, h6: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned device revealed that the tip of the retent pin scrdriver qc hex 12/sht/xl25 was broken off.The fragment was not received and no other issues were idenfified.A dimensional inspection for the retent pin scrdriver qc hex 12/sht/xl25 was not performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces like overtightening the device while assemblance; or by assembling the device in a misaligned position.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.The overall complaint was confirmed as the observed condition of the retent pin scrdriver qc hex 12/sht/xl25 would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: part number: 03.045.008-us, lot number: 427p976, manufacturing site: hägendorf, release to warehouse date: 15.12.2021.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: RETENT PIN SCRDRIVER QC HEX 12/SHT/XL25
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): WERK HAEGENDORF; im bifang 6; haegendorf CO ; SZ
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24533287
• Report Number: 8030965-2026-02302
• Device Sequence Number: 13376573
• Product Code: HXX
• UDI-Device Identifier: 10886982292551
• UDI-Public: (01)10886982292551(10)427P976
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.045.008
• Device Lot Number: 427P976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 03/24/2026; 04/09/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 03/26/2026; 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.7MM CANN DRILL BIT QC/ 145MM; 511.774; DRIVE SHAFT FOR RIA 2 520MM; MONOBLOC FLEX REAMER 14.5 - LONG - DD; MONOBLOC FLEXIBLE REAMER 14 - STD - DD; SCRDRIVER-HEX-SMALL W/HOLD-SLEEVE; T15 CANN STRDRV SCRWDRVR SFT SLF-RETAIN; T15 CANN STRDRV SCRWDRVR SFT SLF-RETAIN; T25 SDDRIVE SCREWDRIVER SHAFT 241MM; T25 SDDRIVE SCREWDRIVER SHAFT 241MM
• Patient Sex: Unknown