MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US RECLAIM ASSEMB TOOL ADAPT 85MM; HIP INSTRUMENT/TRIAL

Catalog Number	297500610
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
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 while preparing for a case the spring inside the 85 mm assembly tool adaptor was bent, preventing it from snapping onto the reclaim assembly tool.The case was rescheduled the next day and was able to get a replacement instrument to use.
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4); investigation summary = > examination of the returned instrument confirmed the reported observation.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.
Event or Problem Description
Complaint description: it was reported that while preparing for a case the spring inside the 85mm assembly tool adaptor was bent, preventing it from snapping onto the reclaim assembly tool.The case was rescheduled the next day and was able to get a replacement instrument to use./ | investigation method: / | investigation summary:.

• Brand Name: RECLAIM ASSEMB TOOL ADAPT 85MM
• Common Device Name: HIP INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6820521
• Report Number: 1818910-2017-23472
• Device Sequence Number: 60497
• Product Code: LXH
• UDI-Device Identifier: 10603295155966
• UDI-Public: 10603295155966
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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): 07/26/2017

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: 297500610
• Device Lot Number: SO2002961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2017
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR