MAUDE Adverse Event Report: SYNTHES GMBH SCRDRIVER W/QUICK-COUPL HEX 12 XL25; SCREWDRIVER

Catalog Number	03.045.005
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/30/2025
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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2025, when inserting a 5.0 locking screw into the distal hole of the 170mm tfna, the xl25 power screwdriver shaft and retention pin snapped off.The tip of the screwdriver power shaft and the threads of the retention pin were stuck in the head of the screwdriver.This kept the surgeon from being able to advance the screw or take it out.No screwdriver was able to grab the head of the screw.This left the screw protruding.Surgeon tried to use another screwdriver to remove the screw but the head was taken up by the screw driver pieces inside it.Surgery was delayed by 15 minutes due to the reported event.Procedure was completed successfully.There were patient consequences as the protruding screw head may cause soft tissue irritation post-op.
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: h4 corrected: g1 (manufacturing site name) h3, h4, h6: photo investigation: the product was not returned to j&j medtech orthopaedics, however photos were provided for review.The photo investigation revealed that the scrdriver w/quick-coupl hex 12 xl25 was broken from the distal tip.Additionally the slot shape of the tip was observed twisted.No post-operative x-ray were provided, therefore the embedded condition cannot be confirmed.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces as the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the scrdriver w/quick-coupl hex 12 xl25 would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to component failure, and 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 reported complaint condition.As part of j&j medtech orthopaedics 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.Physical device investigation: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the scrdriver w/quick-coupl hex 12 xl25 was broken from the distal tip.Additionally the slot shape of the tip was observed twisted.The broken fragment was not returned for evaluation.The fracture surface was thoroughly examined and no problems with the material were noted.No post-operative x-ray were provided, therefore the embedded condition cannot be confirmed.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional evaluation was performed several attempts of disassembly were made.It was not possible to disassembly the mating device (03.045.006, retention pin w/quick-coupl hex 12).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined based on the evidence provided.The overall complaint was confirmed as the observed condition of the scrdriver w/quick-coupl hex 12 xl25 would have contributed 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 reported complaint condition.As part of j&j medtech orthopaedics 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 (dhr): part number: 03.045.005-us lot number: 701p847 manufacturing site: hägendorf release to warehouse date: 09-may-2022.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: SCRDRIVER W/QUICK-COUPL HEX 12 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 4614 ; SZ 4614
• Manufacturer Contact: elba bello ; 1302 wrights lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22063145
• Report Number: 8030965-2025-05089
• Device Sequence Number: 7634916
• Product Code: HXX
• UDI-Device Identifier: 10886982292520
• UDI-Public: (01)10886982292520(10)701P847
• Combination Product (Y/N): N
• 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

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: 03.045.005
• Device Lot Number: 701P847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2022
• 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
• Patient Sex: Unknown