MAUDE Adverse Event Report: SYNTHES GMBH INSERT-HANDLE HYBRID; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	03.037.011
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
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.Additional narrative: d4: udi: as the catalog/model number was not provided, the (01)gtin is 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 the surgeon experienced difficulty tightening the locking mechanism onto the blade surface.The statis locking screwdriver assembly was passed through the insertion handle, but it was uncertain whether it had fully engaged through the cannulated connecting screw.The surgeon suspected it was not properly seated in the hexagonal recess of the lock drive, as clockwise advancement was not possible.Multiple attempts were made using both the flexible screwdriver (03.037.028) and the 5 mm hexagonal screwdriver shaft (03.027.029), but without success.The surgeon then attempted a few light mallet taps to help engage the lock drive, which also failed.The surgeon decided to remove the nail for inspection.However, when attempting to detach the hexagonal screwdriver shaft, it could not be disconnected from the insertion handle.As a result, the entire construct (hexagonal screwdriver shaft, insertion handle, and nail) had to be removed as one piece.The surgeon proceeded with a second instrument set and a new nail.Using the same steps, the surgeon was able to advance the locking mechanism successfully with the 5 mm flexible screwdriver passed through the connecting screw and insertion handle, ensuring proper engagement with the locking mechanism.Procedure was completed successfully with a 15 minute surgical delay.A second instrument set was used to complete the surgery.
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, catalog), h4.Corrected: d1, d2a, d2b, d4 primary udi number, g1.H3, h6: the product was not returned to depuy synthes, however photos were provided for review.See attachment (f268fd1b-8b09-4391-929c-e8016189dd0d.Jpeg).The photo investigation revealed nothing confirmative of a nonconformance, as the reported issue might be caused by internal damage on a device, witch cannot be observed based on the evidence provided.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the unk - nail insertion handles would have not 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 review: (b)(6).27/01/2026.Part number: 03.037.011.Lot number: 62p8919.Manufacturing site: hägendorf.Release to warehouse date: 31-july-2020.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.
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: h6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.H3, h6: photo investigation: the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed nothing confirmative of a nonconformance, as the reported issue might be caused by internal damage on a device, witch cannot be observed based on the evidence provided as the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the unk - nail insertion handles would have not 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 review.The device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: INSERT-HANDLE HYBRID
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HAEGENDORF; im bifang 6; haegendorf CO ; SZ
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 23887329
• Report Number: 8030965-2025-12919
• Device Sequence Number: 4771575
• Product Code: HSB
• UDI-Device Identifier: 07611819642379
• UDI-Public: (01)07611819642379(10)62P8919
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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: 03.037.011
• Device Lot Number: 62P8919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 01/19/2026; 02/04/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/20/2026; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2020
• 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