MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE GRIPTION TF; HIP INSTRUMENTS : HANDLES

Catalog Number	221701503
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
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.
Event or Problem Description
It was reported that two gription tf surgical instrument became cold welded together during this patient's primary hip arthroplasty surgery.Both a rasping strike plate and an augment finishing rasp were attached to an augment rasping handle, and the instruments were then used in the patient's surgical procedure.After the surgery had been completed, the strike plate could not be physically separated from the rasping handle by the scrub tech nor the sales rep.The two instruments were therefore sent to sterile processing still attached to one another for cleaning.The loaner instruments, which included the strike plate and rasping handle, were returned to the distributor's warehouse, where members of the warehouse staff attempted to separate the two instruments.They too were unable to separated the instruments, so replacement instruments are now needed to complete the loaner tray.

• Brand Name: PINNACLE GRIPTION TF
• Common Device Name: HIP INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24851883
• Report Number: 1818910-2026-06595
• Device Sequence Number: 5651855
• Product Code: HXC
• UDI-Device Identifier: 10603295097846
• UDI-Public: (01)10603295097846(10)SO2001517
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 04/10/2026

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: 221701503
• Device Lot Number: SO2001517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2021
• 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 Age: 58 YR
• Patient Sex: Female