MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE DISTAL FEMORAL JIG; KNEE INSTRUMENT/TRIAL

Catalog Number 254400520

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Date 04/08/2015

Event Type  malfunction  

Event Description

For attune® intuition distal femoral jig (part numbers 254400521 and 254400520), as the metal pin bushing came out during a bilateral attune tkr case on (b)(6) 2015.

Manufacturer Narrative

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.

Manufacturer Narrative

The complaint was received into the leeds complaint department 10 april 2015 with the comment: for attune® intuition distal femoral jig (part numbers 254400521 and 254400520), as the metal pin bushing came out during a bilateral attune tkr case on (b)(6) 2015.No product was returned for investigation.In some instances the bush had been assembled incorrectly making it easy to be pushed out with very little force.This was identified as a supplier fault and corrective actions have been put in place to prevent reoccurrence.In other instances it was found that bush had been assembled correctly but the surgeons had not followed the surgical technique and thus put excessive loading on the bush causing it to break and fall out.It is advised in the attune surgical technique (0612-10-512) that on uncut bone, non-headed pins be used to minimise the effect of the pin head pulling the jig out of alignment on to the bone surface.This will also minimise abnormal/excessive loading on the jig and potential misalignment of the distal cut through poor jig positioning.In this instance the cause of the problem cannot be determined due to the product not being returned for investigation.Bushing retention complaints from the dfj have been escalated through the depuy synthes quality systems to evaluate the risks of this failure mode (qrb 103077521) with a field notice issued reinforcing correct pinning technique.The cause of the complaint is undetermined.It will be entered into the complaint database and monitored through trend analysis.Should further information be provided then the complaint may be reopened for further investigation.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: ATTUNE DISTAL FEMORAL JIG
• 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: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4698754
• MDR Text Key: 5673631
• Report Number: 1818910-2015-18799
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254400520
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2015
• 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