MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SET/3 VELCRO STRAPS; WRIST INSTRUMENT/TRIAL

Catalog Number	284112000
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	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 the hook-and-loop fasteners were packaged with the wrong ifus.It is also reported that the product is a one-time use product however the ifu is for a reusable device.The product labeling is correct.
Additional Manufacturer Narrative
The investigation confirmed the reported discrepancy between the product label and product guide.Depuy considers the investigation closed.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: SET/3 VELCRO STRAPS
• Common Device Name: WRIST INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6800740
• Report Number: 1818910-2017-22957
• Device Sequence Number: 1247195
• Product Code: LXH
• UDI-Device Identifier: 10603295155027
• UDI-Public: 10603295155027
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2017

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: 284112000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1