MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE LTL CEM TIBIAL DRILL; DRILLS

Model Number 2545-00-165

Device Problems Component Missing (2306); Device-Device Incompatibility (2919)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 07/24/2020

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 an attune pin puller won't grab pins, an attune tibial drill was missing depth stop holding ball and an attune tibial impactor broke into two pieces.There was a 5 minutes surgical delay reported.All broken pieces were retrieved from the patient.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary :examination of the returned device confirms the reported event.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.H10 additional narrative: corrected: h3, h6 (patient).H6 patient code: no code available (3191) was used to capture prolonged surgery and insufficient information.

• Brand Name: ATTUNE LTL CEM TIBIAL DRILL
• Type of Device: DRILLS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10367764
• MDR Text Key: 201701249
• Report Number: 1818910-2020-17617
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10603295445647
• UDI-Public: 10603295445647
• 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: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2545-00-165
• Device Catalogue Number: 254500165
• Device Lot Number: NG56738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR