MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE TIBIAL TRIAL EXTRACTOR; KNEE INSTRUMENT/TRIAL

Catalog Number 254500138

Device Problem Break (1069)

Patient Problem No Information (3190)

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).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The extractor has a chip on the edge of the extractor prong.

Manufacturer Narrative

This complaint remains under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.

Manufacturer Narrative

Examination of the returned device confirms the reported event of breakage.Pra (preliminary risk assessment) (b)(4) was held on 25 jan 2016 to evaluate the increased complaints involving the attune tibial trial extractor (product code 254500138).The review team determined that there was no increased patient risk.Based on a previous evaluation (b)(4) for a similar failure by depuy material science, the root cause is attributed to overload.Based on the root cause of overload and pra (preliminary risk assessment) (b)(4) determination of no additional patient risk, corrective action was not indicated.Continue to monitor via sep-419.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: ATTUNE TIBIAL TRIAL EXTRACTOR
• 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: 5977783
• MDR Text Key: 55632502
• Report Number: 1818910-2016-28077
• Device Sequence Number: 1
• Product Code: HWB
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254500138
• Device Lot Number: BFA10C7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2016
• Initial Date FDA Received: 09/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/31/2016; 11/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2015
• 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