MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SPECIALIST*2 UNIVERSAL HANDLE; KNEE INSTRUMENT/TRIAL

Catalog Number 966520

Device Problem Component Missing (2306)

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

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The metal piece was broken around the tip.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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 returned sp2 universal handle confirmed the breakage at the square-to-circular (.183 dimension) cross-section changes of the distal end of the external rod sub-component.The overall condition of the instrument indicates heavy usage and impactions over time.A design modification to change to the undercut details of the square-to-circular (.183 dimension) cross-section was implemented in december 2012 via eco400749 (rev.F) to reduce incidence of instrument failure.A search of the complaint database against product code 966520 did not find any reports of fracture manufactured after the december 2012 design modification.Although the submitted sp2 universal handle was manufactured prior to the design modification, it has been subjected to heavy usage and the root cause is attributed to normal use and servicing.The submitted sp2 universal handle was manufactured prior to the design modification in december of 2012 and the need for corrective action is not indicated.Monitor for reported events of fracture for sp2 universal handles manufactured after december 2012.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.

• 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: 6159155
• MDR Text Key: 62137922
• Report Number: 1818910-2016-33203
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944538
• 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,Followup
• Report Date: 12/06/2016

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: 966520
• Device Lot Number: J0706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/09/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/20/2016; 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2006
• 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