MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS DISASSEMBLY TOOL; HIP INSTRUMENTS : EXTRACTION INSTRUMENTS

Catalog Number 298771000

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 04/15/2019

Event Type  malfunction  

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.

Event Description

The surgeon used the lps disassembly tool with the intention of altering the version of the prosthesis.The teeth of the tool broke off in situ and the disassembly tool was unable to be used for its intended purpose.All metal particulate was cleared from the surgical site and the surgeon was satisfied that it was safe to continue.There was no alternative tool available.An alternative solution was found to achieve the intended result without disassembling the prosthesis.The debris was cleared from the surgical site, 5 minute delay to the procedure.No ae to patient.

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.Product complaint #: (b)(4).Investigation summary: the device was reviewed and confirmed the teeth had broken off the device.The pieces were not returned however the complaint states all pieces were retrieved.Root cause attributed to the device being worn from normal use and servicing.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint (b)(4).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.

• Brand Name: LPS DISASSEMBLY TOOL
• Type of Device: HIP INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8583658
• MDR Text Key: 144183557
• Report Number: 1818910-2019-92625
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295159087
• UDI-Public: 10603295159087
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 298771000
• Device Lot Number: AK0607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 05/06/2019
• Supplement Dates Manufacturer Received: 05/15/2019; 07/01/2019
• Supplement Dates FDA Received: 06/07/2019; 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1