MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 VV NAVIGATED MI INSERTER; HIP INSTRUMENTS : IMPACTORS

Catalog Number	229990030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the plastic clips broke off from the handle and the locking mechanism will not work for item # (b)(4).Product broke into 2 pieces and all pieces were retrieved and this did not cause any delay in the surgery.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary examination of the device confirmed the failure mode as reported.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.

• Brand Name: VV NAVIGATED MI INSERTER
• Common Device Name: HIP INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7931842
• Report Number: 1818910-2018-71235
• Device Sequence Number: 1346818
• Product Code: HAW
• UDI-Device Identifier: 10603295115298
• UDI-Public: 10603295115298
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K052178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2018

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: 229990030
• Device Lot Number: PS0706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 10/17/2018; 11/15/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 10/25/2018; 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1