MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SP2*REAMER T-HANDLE; KNEE INSTRUMENT : HANDLES

Catalog Number	966648
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: examination of the returned device did not confirm the reported event.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.Occupation: non-healthcare professional ¿ depuy quality product analyst.
Event or Problem Description
Product (b)(4) was received with (b)(4) but was not reported with that pc.Functional evaluation of the returned t-handle without mating a component found the locking mechanism to function with no restrictions.Functional evaluation with a retained reamer found the instrument to assemble, retain, and disassemble with no restrictions.Overall appearance exhibited normal wear marks and scratches due to normal usage and servicing.The investigation could not draw any conclusions about the root cause of the reported failure mode, however, indications of device wear through normal use and servicing is evident.
Additional Manufacturer Narrative
Product complaint: (b)(4).

• Common Device Name: KNEE INSTRUMENT : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7876253
• Report Number: 1818910-2018-69357
• Device Sequence Number: 16188491
• Product Code: LXH
• UDI-Device Identifier: 10603295249344
• UDI-Public: 10603295249344
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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: 966648
• Device Lot Number: H0106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1