MAUDE Adverse Event Report: SYNTHES GMBH FEMORAL BROACH ADPT - STRAIGHT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	200002102
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unspecified surgical procedure it was observed that the broach adaptor device, when used with an unknown battery handpiece had low power and not enough force, and metal was chipping away around the hole.It was reported that there was an unspecified delay in the procedure due to the event.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.H10 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.H11 additional narrative: added: d9 the device was functionally / visually tested according to the diagnostic assessment.The described failure by the customer was confirmed.The device was visually inspected as received from the customer.It was found that the device failed visual inspection due to damaged guide pin.Investigation is based on technical investigator findings.The device failed following inspection criteria¿s during diagnostic assessment: 4.3.5 visual assessment: fail 4.3.53 broach locking lever: fail the device was visually and functionally assessed and it was found that the broach could not be inserted/removed due to damaged guide pin, consistent with broach not being properly secured ¿ user error.The most relevant root cause is linked to improper handling - user error.As part of anspach quality process all devices are manufactured, inspected, and released to approved specifications.The instructions for use states the following regarding the reported issue that was observed by the user or customer: raise the locking latch to the fully open position.Using an approved broach, insert the broach pin into the broach adapter locator while also aligning the broach adapter guide pin with the locator opening on the broach.Lower the locking latch to the fully closed position.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history review: no manufacturing record evaluation required as no manufacturer or service related issue found.

• Brand Name: FEMORAL BROACH ADPT - STRAIGHT
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: elba bello ; eimattstrasse 3; oberdorf 04436 ; SZ 04436 ; 9083863534
• MDR Report Key: 24662399
• Report Number: 8030965-2026-02735
• Device Sequence Number: 18441178
• Product Code: HWE
• UDI-Device Identifier: 07612334268693
• UDI-Public: (01)07612334268693(10)NW347056
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 200002102
• Device Lot Number: NW347056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2024
• 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