MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 54MM GRIPPER; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number	221890054
Medical Device Problem Codes	Break (1069); Material Discolored (1170)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint : (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Reason for revision: pre-prosthetic fracture of femoral component & dislocation.Primary implant date: not available.Issue: ab gripper insertion instrument broke at the time of use, a small piece was retrieved from the patient, the procedure was completed without the instrument.Surgery delayed less than 5mins.
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Investigation summary = > examination of the returned device(s) confirms the reported event.Product problem has not been identified.Failure determined to be due to wear and tear.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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.Product complaint #: (b)(4).

• Brand Name: PINNACLE 54MM GRIPPER
• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8508550
• Report Number: 1818910-2019-90516
• Device Sequence Number: 1650442
• Product Code: LXH
• UDI-Device Identifier: 10603295102298
• UDI-Public: 10603295102298
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/20/2019

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: 221890054
• Device Lot Number: A0608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2019
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 05/05/2019; 06/12/2019; 06/12/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 05/07/2019; 06/12/2019; 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR