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

Catalog Number 221890054

Device Problems Break (1069); Material Discolored (1170)

Patient Problem Not Applicable (3189)

Event Date 03/20/2019

Event Type  malfunction  

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 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.

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.

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.

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
• Type of Device: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8508550
• MDR Text Key: 141742619
• Report Number: 1818910-2019-90516
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295102298
• UDI-Public: 10603295102298
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR