MAUDE Adverse Event Report: DEPUY-RAYNHAM, DIV OF DEPUY ORTHO ¿ REG# 1219655 ATTUNE CR FEM TRIAL SZ 8 LT; KNEE INSTRUMENT/TRIAL

Catalog Number 254500718

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 05/28/2015

Event Type  malfunction  

Event Description

Intraoperatively the trial broke during testing / setting of bone.

Manufacturer Narrative

Additional narrative: this complaint is still under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.

Manufacturer Narrative

Additional narrative: this complaint is under investigation.Depuy will notify the fda of the results of the 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 investigation remains closed, as the added information does not change the outcome of the investigation.

Manufacturer Narrative

Examination of the returned device confirms the reported event of trial breakage.A complaints review was completed in february 2014 and in june 2014 for all attune trial instruments, following (b)(4), inclusive of the attune femoral trials, articulation surface trials, and the patella trials.Findings of the complaints review prompted dfmea updates where applicable.The root cause is attributed to user technique and/or misuse.The damage suggests the trial was pryed or otherwise inappropriately removed during trialing.Based on the root cause of suspected misuse, corrective action is not needed.Monitor subsequent reports via (b)(4).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 CR FEM TRIAL SZ 8 LT
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY-RAYNHAM, DIV OF DEPUY ORTHO ¿ REG# 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY-RAYNHAM, DIV OF DEPUY ORTHO ¿ REG# 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4823443
• MDR Text Key: 5903955
• Report Number: 1818910-2015-22858
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK140881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254500718
• Device Lot Number: MVMBWD160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1