MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC KINCISE¿ PINNACLE® SHELL/LINER IMPACTOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number	1011-01-101
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
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: e1: the reporter¿s complete facility address was not provided.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
It was reported that during an unspecified surgery the cross bar on the shell/liner impactor device broke off during impaction.There were no delays to the surgical procedure.It was not reported if a spare device was available for use.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.
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: correction: d4 primary udi number corrected.H4: the device manufacture date has been added.Investigation summary: device history review: product was not returned.Review of the device history record(s) showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.

• Brand Name: KINCISE¿ PINNACLE® SHELL/LINER IMPACTOR
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): TECHTRONIC INDUSTRIES MEDICAL; 1428 pearman dairy rd; anderson SC 29625
• Manufacturer Contact: elba bello ; eimattstrasse 3; oberdorf 04436 ; SZ 04436 ; 9083863534
• MDR Report Key: 24293969
• Report Number: 1045834-2026-00037
• Device Sequence Number: 9426629
• Product Code: GEY
• UDI-Device Identifier: 00845384018575
• UDI-Public: (01)00845384018575
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 02/09/2026

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: 1011-01-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2022
• 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