MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 CUP INTRODUCER 36MM; HIP INSTRUMENT/TRIAL

Catalog Number	962600036
Medical Device Problem Codes	Break (1069); Component Missing (2306)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/09/2017
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
It was reported that item discovered to be missing a small lug screw by the ortho technician when packing the set after being washed and sterilised.It was assumed that screw has worked loose and fallen out in the washing / sterilisation process.
Additional Manufacturer Narrative
Additional narrative: depuy considers the investigation closed at this time.Should the 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.
Additional Manufacturer Narrative
It was reported that item discovered to be missing a small lug screw by the ortho technician when packing the set after being washed and sterilised.It was assumed that screw has worked loose and fallen out in the washing / sterilisation process.The reported event has been evaluated and will be monitored.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: CUP INTRODUCER 36MM
• Common Device Name: HIP INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6851574
• Report Number: 1818910-2017-24289
• Device Sequence Number: 41147
• Product Code: HWR
• UDI-Device Identifier: 10603295243267
• UDI-Public: 10603295243267
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2017

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: 962600036
• Device Lot Number: 0MS581024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2017
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 10/03/2017; 10/11/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 10/03/2017; 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1