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

Catalog Number 217870000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 08/07/2017

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the paddle did not open properly.

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.

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 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
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6846364
• MDR Text Key: 85022255
• Report Number: 1818910-2017-24143
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295096726
• UDI-Public: 10603295096726
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1