MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. HP MBT CEM KEEL PUNCH; KNEE INSTRUMENT/TRIAL

Catalog Number 950502011

Device Problem Disassembly (1168)

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

Event Date 02/08/2017

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.Depuy synthes has been informed that the catalog number and lot number is not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The keel punch was not properly assembling to the handle.Once assembled it was very difficult to remove from the handle.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

(b)(4).Functional evaluation of the submitted device with a retained hp mbt keel punch impact replicated the reported problem, visual examination of the submitted device found significant wear on both locking tab features.The root cause is attributed to device wear form normal use and servicing.The device is old and has been subjected to heavy usage over time.Based on the root cause determination of device wear form normal use and servicing, the need for corrective action is not indicated.Monitor complaints through sep-419.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: HP MBT CEM KEEL PUNCH
• 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: 6376958
• MDR Text Key: 69270217
• Report Number: 1818910-2017-13946
• Device Sequence Number: 1
• Product Code: LRY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 950502011
• Device Lot Number: J0709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2009
• 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
• Patient Age: 59 YR