MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.1818910 HP EM TIBIAL JIG ANKLE CLAMP; KNEE INSTRUMENT/TRIAL

Catalog Number 950501229

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the blue distal knob will not tighten.This is the mid part of the sigma hp extramedullary tibial cutting guide.

Manufacturer Narrative

The device associated with this reported event was not received for examination.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: HP EM TIBIAL JIG ANKLE CLAMP
• 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: 6894331
• MDR Text Key: 87517805
• Report Number: 1818910-2017-25405
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295225348
• UDI-Public: 10603295225348
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 950501229
• Device Lot Number: NT0309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/15/2009
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1