MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 LOCKING SCREWDRIVER ROD; EXTREMITY INSTRUMENTS : SCREWDRIVERS

Catalog Number	230792004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2018
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.
Event or Problem Description
Maude report received.It was reported, during a reverse shoulder procedure 3 small metal prongs broke off of the depuy locking screwdriver from the delta extend glenoid case complete tray.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the instrument associated with this report was not returned.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LOCKING SCREWDRIVER ROD
• Common Device Name: EXTREMITY INSTRUMENTS : SCREWDRIVERS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 7533591
• Report Number: 1818910-2018-60251
• Device Sequence Number: 13490766
• Product Code: HXX
• UDI-Device Identifier: 10603295116578
• UDI-Public: 10603295116578
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2018

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: 230792004
• Device Lot Number: 5223505
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1