MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US APG+ STRAIGHT HANDLE INNER; EXTREMITY INSTRUMENTS : SCREWDRIVERS

Catalog Number	223000024
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2017
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
It was reported that the global apg straight handle inner was bent and doesn't fit with ease into the handle and it could not be used in the case.The handle was sent bent.No surgical delay.
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned device confirmed the reported damage.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.

• Brand Name: APG+ STRAIGHT HANDLE INNER
• Common Device Name: EXTREMITY INSTRUMENTS : SCREWDRIVERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581
• MDR Report Key: 7142257
• Report Number: 1818910-2017-52478
• Device Sequence Number: 13736216
• Product Code: LXH
• UDI-Device Identifier: 10603295102977
• UDI-Public: 10603295102977
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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: 223000024
• Device Lot Number: PC3000649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1