MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SP2 SIGMA INSET PATELLAR CLAMP; KNEE INSTRUMENT/TRIAL

Catalog Number 966670

Device Problem Break (1069)

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

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.Udi: (b)(4).

Event Description

The clamp will not lock in the drill guide.

Manufacturer Narrative

Examination of the returned device confirms the reported event.The canted coil spring is missing from the clamp.Functional testing with a depuy retained sigma inset patella clamp head (b)(4) confirms the clamp will not hold the head.A prior investigation found the patella clamp will not retain the clamp head when the canted coil spring is missing.Supplier (b)(4) was implemented in (b)(6) 2010 to address disassembled canted coil spring components.The current complaint sample was manufactured prior to (b)(4).Although the complaint sample was manufactured prior to (b)(4), the root cause is being attributed to product wear out.No corrective action required.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: SP2 SIGMA INSET PATELLAR CLAMP
• 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: 6131436
• MDR Text Key: 61026790
• Report Number: 1818910-2016-32344
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 966670
• Device Lot Number: H0205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2005
• 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