MAUDE Adverse Event Report: Synthes GmbH INSRT HNDL FOR MULTILOC HUM NLING SYS; Rod, Fixation, Intramedullary And Accessories

Catalog Number	03.019.006
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported an upper limb surgeon has said he has had the aiming arm and nail miss a couple of times now on multiloc cases.Prior to the case, yesterday, we did check it, it was all aligned but when doing the distal locking for a short nail the drill, it did hit.I suggested tightening up the connection screw, but he felt it and said it was tight.
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.Investigation summary: the product was not returned to depuy synthes; however, photos were provided for review.The photographs attached were reviewed, however the evidence provided was not sufficient to confirm the reported event of misalignment.Functionality and device interaction issues cannot be evaluated through photo investigation.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 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: part: 03.019.006.Lot: l193384.Manufacturing site: werk hagendorf.Supplier: n/a.Release to warehouse date: 03 feb, 2017.Expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.

• Brand Name: INSRT HNDL FOR MULTILOC HUM NLING SYS
• Common Device Name: Rod, Fixation, Intramedullary And Accessories
• 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 ; +1(908)386-3534
• MDR Report Key: 50690254
• Report Number: 8030965-2026-08988
• Device Sequence Number: 5891707
• Product Code: HSB
• UDI-Device Identifier: 07611819425569
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K103002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• 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: 03.019.006
• Device Lot Number: L193384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2017
• 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