MAUDE Adverse Event Report: SYNTHES GMBH HOLD-SLEEVE LRG F/314.190 314.240 314.26; SCREWDRIVER

Catalog Number	314.280
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 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 reassessed.The product was not returned to depuy synthes; however, photos were received for review.The device associated with this report was not returned to medtech orthopedics for evaluation.The photographs attached were reviewed, however the provided evidence was not sufficient to confirm the reported event of the provided evidence was not sufficient to confirm the reported event of "unable to assemble/disassemble ".Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the photographs attached don¿t have any evidence to draw a conclusion about the reported event.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 medtech orthopedics 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.
Event or Problem Description
It was reported that patient underwent extraction of a non-synthes nail on (b)(6), 2025.Synthes extraction equipment was used.The conical nozzle, along with the retaining sheath and sliding guide, were assembled to the nail and could not be detached afterward.All three pieces were sent together in the kit.Additionally, an attempt was made to detach these pieces, but the combination wrench, which was also sent in the kit, broke.

• Brand Name: HOLD-SLEEVE LRG F/314.190 314.240 314.26
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• 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: 23536471
• Report Number: 8030965-2025-11343
• Device Sequence Number: 10202176
• Product Code: HXX
• UDI-Device Identifier: 07611819019959
• UDI-Public: (01)07611819019959
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Health Professional,Company Representative,Distributor
• 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: 314.280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 11/12/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown