MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US G C.A.P. HUM HD SHAPER 52X21; EXTREMITY INSTRUMENTS : REAMERS

Catalog Number	223081080
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/01/2019
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
Global cap reamers not working - locking mechanism was disengaging when pressure is applied.Was surgery delayed due to the reported event? --> yes.If yes, number of minutes: --> 30.Action taken when event occurred? --> tried to lock mechanism once again dental burr was used to achieve similar result as reamer.Was procedure successfully completed? --> yes.Patient status/ outcome / consequences --> no.
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.Product complaint # (b)(4).Investigation summary = > 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.
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.Product complaint # (b)(4).Investigation summary: 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.

• Brand Name: G C.A.P. HUM HD SHAPER 52X21
• Common Device Name: EXTREMITY INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8862000
• Report Number: 1818910-2019-100110
• Device Sequence Number: 1937866
• Product Code: HTO
• UDI-Device Identifier: 10603295105077
• UDI-Public: 10603295105077
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2019

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: 223081080
• Device Lot Number: A0105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 09/03/2019; 09/03/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 09/03/2019; 09/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR