MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC STEM TRIAL EXTRACT; KNEE INSTRUMENT/TRIAL

Catalog Number 865226

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 11/23/2016

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).

Event Description

While inspecting an office set, it was discovered that part 86-5226 was bent at the threads of the stem extractor.

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

Examination of the submitted device confirmed the threaded tip is bent.The root cause is attributed to misuse.The extractor was levered side to side which resulted in the bent tip condition.Based on the root cause determination of misuse, the need for corrective action is not indicated.Continue to monitor complaints through 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.

Event Description

While inspecting an office set, it was discovered that part 86-5226 was bent at the threads of the stem extractor.

• Brand Name: PFC STEM TRIAL EXTRACT
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6147656
• MDR Text Key: 61550086
• Report Number: 1818910-2016-32535
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2016

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: TX6562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/09/2016; 12/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2016
• 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