MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US INDEPENDENT BALANCER; KNEE INSTRUMENT/TRIAL

Catalog Number	217870000
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	08/07/2017
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 the paddle did not open properly.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned device confirmed the reported event.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.
Event or Problem Description
Complaint description: it was reported that the paddle did not open properly.| investigation method: the complaint sample consisted of (3) 217870000 independent balancer, lot codes, nb110243, nb110243, and nb110243.| investigation summary: it was reported that the paddle did not open properly.

• Brand Name: INDEPENDENT BALANCER
• Common Device Name: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6846364
• Report Number: 1818910-2017-24143
• Device Sequence Number: 16154371
• Product Code: HWT
• UDI-Device Identifier: 10603295096726
• UDI-Public: 10603295096726
• 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,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2017

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: 217870000
• Device Lot Number: NB110243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Initial Date Received by Manufacturer: 08/07/2017
• Supplement Date Received by Manufacturer: 09/05/2017; 07/23/2018
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 09/12/2017; 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1