MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US G C.A.P. HUM HD SHAPER 56X18; EXTREMITY INSTRUMENTS : REAMERS

Catalog Number 223081090

Device Problem Device-Device Incompatibility (2919)

Patient Problem Not Applicable (3189)

Event Date 01/01/2019

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

Global cap reamers not working - locking mechanism was disengaging when pressure is applied.

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
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> the products were returned to australia where the engineering technician confirmed the complainants findings.The products were all over 12 years old and showed signs of wear and tear which was deemed to be the reason that the products were not performing as expected.The complaint was found to be justified with a route cause of normal wear.The problem instruments will be disposed of.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: G C.A.P. HUM HD SHAPER 56X18
• Type of Device: EXTREMITY INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8788904
• MDR Text Key: 150971317
• Report Number: 1818910-2019-98226
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295105084
• UDI-Public: 10603295105084
• 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: 06/25/2019

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: 223081090
• Device Lot Number: A0604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 07/16/2019; 09/03/2019
• Supplement Dates FDA Received: 07/24/2019; 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR