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 10/11/2016

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

Pfc jig spiked broken.

Manufacturer Narrative

Conclusion and justification status: the complaint states pfc jig spiked broken.No device was returned hence the complaint cannot be confirmed.Without further information the root cause of the complaint cannot be determined.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Post market surveillance is per sep 419.Depuy still 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.

Manufacturer Narrative

The investigation has been reopened because the product has been received.Depuy will notify the fda of the results of the investigation once it has been completed.

Manufacturer Narrative

The complaint states pfc jig spiked broken.The returned device was reviewed by bioengineering in compact (b)(4) which states the instrument has been returned and returned for investigation.During a visual inspection it was noted that the weld holding the uprod anterior slide and the proximal slide has fractured.Overall, the instrument has carried signs of wear and tear through normal use (as per (b)(4)).Complaints database search on the product code indicated 4 similar complaints, one coming from the same lot (a0809).The complaint shall be closed with a justified conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Post market surveillance is per (b)(4).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: 6043244
• MDR Text Key: 57931175
• Report Number: 1818910-2016-29831
• 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,Followup,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• 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: A0809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2009
• 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