MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE BAL SIZER DISTRACTOR; KNEE INSTRUMENT/TRIAL

Catalog Number 254400519

Device Problem Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 11/17/2015

Event Type  malfunction  

Manufacturer Narrative

This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Followup with the complainant has been conducted for the lot number, and the information is not available.

Event Description

The connection of the two component parts of the jig have become tight.It is difficult assemble and disassemble these two parts due to tight fitting metal components.Event did not occur during surgery.

Manufacturer Narrative

Conclusion and justification status: the complaint states the connection of the two component parts of the jig have become tight.It is difficult assemble and disassemble these two parts due to tight fitting metal components.Event did not occur during surgery.It should be noted that no device was returned to confirm the failure mode.This root cause of this failure mode is attributed to product design.The design is not robust if the ifu is not followed appropriately.The material of the handle has been altered to reduce the chance of galling via (b)(4).It is unlikely there is a manufacturing fault.Post market surveillance is per (b)(4).The complaint shall be closed with a justified conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Depuy still 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.

• Brand Name: ATTUNE BAL SIZER DISTRACTOR
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5270652
• MDR Text Key: 32777433
• Report Number: 1818910-2015-36708
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 11/17/2015

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
• Device Operator: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 254400519
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2015
• Initial Date FDA Received: 12/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1