MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIV REV FEM BROACH HANDLE; KNEE INSTRUMENT : HANDLES

Catalog Number	961682
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device is an instrument and is not implanted/explanted.
Event or Problem Description
It was reported that the mbt rev primary reamer was rounded off where it attaches to the hudson.Mbt rev cam stem reamer was rounded off where it attaches to the hudson.Broach reamer was crossed threaded inside.Modified hudson adapter was rounded off at the contention.Rev reamer t handle was rounded off at the contention.Revision femoral broach handle was worn where it attaches to the broaches and will no longer grab probably.The tip of femoral aug plug puller was worn down.
Additional 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.Device is an instrument and is not implanted/explanted.
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: examination and functional evaluation of the returned device could not replicate the reported event.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.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 will be filed as appropriate.

• Brand Name: UNIV REV FEM BROACH HANDLE
• Common Device Name: KNEE INSTRUMENT : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8330849
• Report Number: 1818910-2019-84087
• Device Sequence Number: 11009412
• Product Code: LXH
• UDI-Device Identifier: 10603295239802
• UDI-Public: 10603295239802
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2019

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: 961682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 02/27/2019; 03/19/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 03/07/2019; 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1