MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG HP BAL RP FEM POSITIONER; KNEE INSTRUMENT : ALIGNMENT DEVICES

Catalog Number	950502144
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary.Examination of the submitted device confirmed the reported wear.Depuy considers the investigation closed.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.
Event or Problem Description
It was reported that the rubber o-ring at the shim-attachment holes wears off and rubber parts fall off during surgery.No surgical delay.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the submitted device confirmed the reported wear.Depuy considers the investigation closed.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.

• Brand Name: SIG HP BAL RP FEM POSITIONER
• Common Device Name: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7821964
• Report Number: 1818910-2018-67825
• Device Sequence Number: 1573530
• Product Code: HWT
• UDI-Device Identifier: 10603295228455
• UDI-Public: 10603295228455
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2018

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: 950502144
• Device Lot Number: B1012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1