MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. HP EM TIBIAL JIG SPIKED UPROD; KNEE INSTRUMENT/TRIAL

Catalog Number 950501230

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 09/01/2016

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

Instrument broken at the weld.

Manufacturer Narrative

Examination of the submitted device found the dial and thumb button non-functional.The root cause is attributed to product design.On january 5, 2009, via (b)(4), miscellaneous changes were made to (b)(4) to address field complaints against the locking mechanism.No further corrective action required.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: HP EM TIBIAL JIG SPIKED UPROD
• 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: 5986536
• MDR Text Key: 55894777
• Report Number: 1818910-2016-28395
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• 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
• Report Date: 09/01/2016

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: 950501230
• Device Lot Number: A1009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2016
• Initial Date FDA Received: 09/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2009
• 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