MAUDE Adverse Event Report: SYNTHES GMBH DRIVING CAP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.043.028
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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 multiple devices are no longer functional.These issues did not impact patient outcomes.Below devices were found to be "release mechanism broken" during inspection: 03.043.028.Below devices were found to be "stripped threads" during inspection: 03.120.022 312.648 323.029 below devices were found to be "nut stuck on sleeve" during inspection: 03.037.017 03.037.016 below devices were found to be "handle leaching/spd wil not sterilize" during inspection: 03.100.018 below devices were found to be "broken handle" during inspection: 311.43 below devices were found to be "stripped drill connection and 2nd is cold welded to a schanz pin" during inspection: 393.103 below devices were found to be "broken sliding mechanism" during inspection: 319.091 below devices were found to be "not snapping in" during inspection: 03.120.018 03.120.017 below devices were found to be "stripped" during inspection: 03.010.151 314.467 03.900.042 03.130.010 314.453 03.010.150 03.010.152.Below devices were found to be "not working properly" during inspection: 329.15 below devices were found to be "not locking tension between trigger pulls" during inspection: 03.221.015 below devices were found to be "not aligned" during inspection: 398.65 below devices were found to be "not locking into aiming arm" during inspection: 03.231.007 below devices were found to be "bent handle" during inspection: 393.1 below devices were found to be "trigger detached from handle" during inspection: 03.221.007 below devices were found to be "not sliding properly" during inspection: 319.006 below devices were found to be "shaft pulls out of handle" during inspection: 314.118 below devices were found to be "not locking on" during inspection: 351.16j below devices were found to be "binding on qc attachments" during inspection: 511.773 below devices were found to be "ends not aligning" during inspection: 03.221.011.(b)(4) is the mother complaint.(b)(4) are related to each other and are created to capture additional ips.
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: b5.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
Additional information received: a.Date of event (mm/dd/yyyy): - items identified at various times in preop testing over the last few months.
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: d4 (lot, expiration date), d9, h4.Corrected: d4 primary udi number, g1.H3, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found the weld of the pin was broken.Pin was not returned for analysis.A complete functional test cannot be performed due to breakage and missing pin, however, due to this condition the spring and pull button were unattached confirming the compliant condition.Note: a driving cap from family 03.043.028 was evaluated and investigated by r&d.Please refer to the attachment "memo chu for 03.043.028 driving cap" for the investigation report.The observed condition of the pin has been previously assessed by materials and testing.Materials and testing provided drafted report that showed some deficiencies in the weld.Conclusion from r&d was that although the weld might not be perfect there must be some significant load leading to the failure of the weld.Materials and testing subsequently performed a finite element analysis to investigate origin of stress at the interface between cross pin and pull button.Analysis showed that strong off axis hammer blows can lead to oscillations in the system that can cause stress that can lead to breakage of the laser weld at the end of the pin and subsequent migration.Surgical technique guide se_814685 mentions at page 16: to use the hammer, attach the driving cap to the insertion handle and secure it by twisting it one quarter turn.Apply light and controlled hammer blows to seat the nail.Notes: the hammer guide may aid in controlling the direction of the hammer blows.Therefore, the hammer guide can be attached to the back end of the drive cap by screwing both parts together.A dimensional inspection was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the driving cap 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 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 lot: part:03.043.028, lot:22234101, manufacturing site: werk selzach, supplier: (b)(4), release to warehouse date: 06 jun 2023, expiration date; na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Note: dhr information was retrieved from (b)(4) as it is the same lot number.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DRIVING CAP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO ; SZ
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24183185
• Report Number: 8030965-2026-00897
• Device Sequence Number: 18567608
• Product Code: LXH
• UDI-Device Identifier: 10886982297389
• UDI-Public: (01)10886982297389(17)411231(10)22234101
• 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: 03.043.028
• Device Lot Number: 22234101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 01/28/2026; 02/17/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/06/2026; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2023
• 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