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

Catalog Number 950501229

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The arm on the side of the sigma ankle clamp broke during surgery.

Manufacturer Narrative

The 950501229 hp em tibial jig ankle clamp associated with this report was not returned.A complaint database search against product code 950501229 finds additional reported incidents of damage.Previous investigations were conducted and the root cause was attributed to design.On january 5, 2009, via eco 284874, miscellaneous changes were made to drawings 114208 and 114224 to address field complaints against the locking mechanism.The investigation could not draw any conclusions about the current reported event without the device to examine.Based on the inability to determine a root cause, a need for corrective action is not indicated.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.

• Brand Name: HP EM TIBIAL JIG ANKLE CLAMP
• 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: 6363825
• MDR Text Key: 68518965
• Report Number: 1818910-2017-13624
• 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: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 950501229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 59 YR
• Patient Weight: 109