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

Catalog Number	03.010.523
Medical Device Problem Codes	Break (1069); Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a poly trauma case, the surgeon ran into several issues with broken product which occurred or was noticed during the procedure.On insertion of a tfna nail into a severely comminuted proximal third femoral shaft fracture, the impactor broke and fell onto the floor.There is no lot number associated with this product as all numbers have been faded from the impactor after repetitive use.During the same procedure, after insertion of the tfna lag screw, the lag screw inserter and the lag screw coupling device have become fused together and will not separate.It was possible to dislodge the device from the tfna screw, but there is no way to now remove the coupling device from the inserter.On the same patient, a tibial nail was also completed.When attempting to load the tna onto the insertion handle, they were unable to attach the nail due to the tabs on the attachment site being bent.It would not allow the nail to insert onto the device appropriately or for the connecting bolt to insert to required depth to attach to the tna nail.To solve this issue, they opened a second tna set and were able to secure a nail to this device for insertion and complete the rest of the case without issue.Patient impact for this case would be the time delay for the opening of a second tna set, and the opening of a second tfna insertion set to get a new impactor.
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.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.H3, h6: the product was not returned to depuy synthes, however photos were received for review.The photo revealed the distal tip of the device was broken.Broken fragment was not observed on photo.Breakage of the device can be confirmed, however, illegible etching can not be confirmed due to complete shaft can not be inspected through photo evidence.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces.Properly handling and attention to the approved use of the device diminishes the risk of failure.Per the frn-advanced femoral recon nailing system (frna) surgical technique, the following relevant statement was found: to use a hammer, screw the driving cap into the insertion handle and tighten with the ratchet wrench.While applying light blows, monitor the tip of the nail using image intensification.Verify that there is no evidence of impingement distally.Remove the driving cap once the nail has been seated.Notes: using light blows, the hammer can also be used with the driving cap to back slap the nail if the nail has been slightly over inserted.Alternatively, the hammer guide can be attached to the driving cap to facilitate the use of the hammer.Confirm that the driving cap is tightly connected to the insertion handle, as hammering may loosen the connection.Precautions: do not strike the insertion handle directly.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 confirmed as the observed condition of the driving cap f/insertion handle 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 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.

• Brand Name: DRIVING CAP/THREADED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 25116986
• Report Number: 8030965-2026-04378
• Device Sequence Number: 21394628
• Product Code: LXH
• UDI-Device Identifier: 07611819499188
• UDI-Public: (01)07611819499188
• 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

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: 03.010.523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown