MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SIG HP FB TIBIA PREP CASE; KNEE INSTRUMENT/TRIAL

Catalog Number 950502812

Device Problem Delamination (2904)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this 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.

Event Description

The plastic that coats the inner instrument holders is peeling.

Manufacturer Narrative

Examination of the submitted device confirmed the brackets are delaminating.The instrument cases lot codes indicate manufactured dates of 2008 through 2010.A search of the complaint database found additional reports of bracket delamination for sigma hp instrument cases.Previous investigation did not conclusively determine the root cause, although it is the supplier manufacturing process related.Details of this issue have been documented through (b)(4) and capa (b)(4).Monitor through trend analysis via (b)(4).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.

• Brand Name: SIG HP FB TIBIA PREP CASE
• 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: 5983201
• MDR Text Key: 55810119
• Report Number: 1818910-2016-28271
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 950502812
• Device Lot Number: DV3BM4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2009
• 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