MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 HP MBT KEEL PUNCH IMPACT; TIBIAL KEEL PUNCH/BULLET

Catalog Number 950502024

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2016

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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

It was reported that the problems appeared gradually due to wear of the posts on the keel punch.The handle slips off even when set screw is thightened and keel punch is new.

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).Investigation summary
=
> functional evaluation of the submitted device could not replicate the reported problem.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: HP MBT KEEL PUNCH IMPACT
• Type of Device: TIBIAL KEEL PUNCH/BULLET
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7263080
• MDR Text Key: 99991651
• Report Number: 1818910-2018-53225
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295227441
• UDI-Public: 10603295227441
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 950502024
• Device Lot Number: NB53186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2017
• 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