MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PATELLA DRILL CLAMP; ATTUNE INSTRUMENTS : PATELLA HANDLE/CLAMPS

Catalog Number 254501041

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2018

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.

Event Description

Attune patella clamp has been complained about by a few reps.The biggest complaint is the amount of force needed to release the attune patella clamp.Patient consequence? :no.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

Manufacturer Narrative

(b)(4).Investigation summary the device associated with this report was not returned.Depuy considers the investigation closed at this time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE PATELLA DRILL CLAMP
• Type of Device: ATTUNE INSTRUMENTS : PATELLA HANDLE/CLAMPS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7251127
• MDR Text Key: 99332291
• Report Number: 1818910-2018-52472
• Device Sequence Number: 1
• Product Code: HXD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254501041
• Device Lot Number: NW138438
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2018
• Date Device Manufactured: 09/09/2013
• 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