MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SIG HP FB STB INSERT TRIAL CSE; KNEE INSTRUMENT/TRIAL

Catalog Number 950502814

Device Problem Delamination (2904)

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

Event Date 03/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Examination of the submitted device confirmed bracket delamination.A search of the complaint database found additional reports of bracket delamination for sigma hp instrument cases against the complaint sample product code.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 pra / hhe (b)(4) and capa (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.

Event Description

The trays are delaminating.

• Brand Name: SIG HP FB STB INSERT TRIAL CSE
• 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: 5541985
• MDR Text Key: 41681917
• Report Number: 1818910-2016-16550
• 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
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 950502814
• Device Lot Number: CS3C44
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1