MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. PFC STEM TRIAL EXTRACT; KNEE INSTRUMENT/TRIAL

Catalog Number 865226

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 09/27/2016

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.(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

Extractor shaft has come away from handle.Threaded tip has snapped off.

Manufacturer Narrative

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

Manufacturer Narrative

Conclusion and justification status for mdr: examination of the submitted 865226 pfc stem trial extract confirmed the threaded tip has broken off and was not returned.The investigation also confirms the breakage of the shaft from the handle.The observed breakage is consistent with ductile overload.The root cause of the ductile overload is attributed to suspected levering of the instrument side to side while attempting to remove the fluted rod from the patient bone canal.No evidence was found indicating product error was a contributing factor and the need for corrective action was not indicated.Continue to monitor via sep-419.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: PFC STEM TRIAL EXTRACT
• 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: 6043390
• MDR Text Key: 57982376
• Report Number: 1818910-2016-29840
• 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: 10/11/2016

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: 865226
• Device Lot Number: G0508G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 10/20/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/07/2016; 11/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2008
• 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