MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS CASE COMPLETE; HIP INSTRUMENT/TRIAL

Catalog Number 201206300

Device Problem Delamination (2904)

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

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 rubber broach holders are starting to lose parts.September 15, 2017 - evaluation of the returned cases found some of the brackets are delaminating.(b)(6).

Event Description

Complaint description: it was reported that the rubber broach holders are starting to lose parts.September 15, 2017 - evaluation of the returned cases found some of the brackets are delaminating.(b)(6) / | investigation method: the complaint samples consisted of (5) 201206300 tri-lock bps case complete, lot number cv4f84.Visual analysis found the material on a few of the brackets on each tray are peeling off; delaminating.Not all the brackets are exhibiting the peeling.A two-year search of the complaint database found additional reports for this issue for this product code; however appear to be attributed to heavy usage.A complaint database search finds no other reported incidents against the provided product and lot combination.Complaints will be monitored under post market surveillance (b)(4)./ | investigation summary: johnson & johnson canada reports that the rubber broach holders are starting to lose parts.September 15, 2017 - evaluation of the returned cases found some of the brackets are delaminating.Examination of the returned trays confirmed the complaint; the material on a few of the brackets are peeling off.The root cause appears to be attributed to heavy usage.Review of the as400 found this lot was placed into distribution in 2010.A complaint database search finds no other reported incidents against the provided product and lot combination.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the investigation, the need for corrective action is not indicated.Complaints will be monitored under post market surveillance (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the reported observation.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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TRI-LOCK BPS CASE COMPLETE
• Type of Device: HIP INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6928163
• MDR Text Key: 89590052
• Report Number: 1818910-2017-26194
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 10603295082323
• UDI-Public: 10603295082323
• 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
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201206300
• Device Lot Number: DV4F84
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Date Manufacturer Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1