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

Model Number 2545-00-165

Device Problems Break (1069); Contamination /Decontamination Problem (2895)

Patient Problem Not Applicable (3189)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the returned device confirmed the reported event.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

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 after attune rp tibial prep was completed the surgeon noted two small green colored foreign objects in the wound.One piece about 1/2 inch long and about 2-3 mm wide, the second piece shorter but about same width.It took a minute ot two ro figure out the foreign bodies were from the green color band of ltl cemented tibial drill, part# d254500165.The wound was doubled recheck and the case proceeded without further incidence.A surgical delay of 2-3 minutes.

Manufacturer Narrative

Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 9525773
• MDR Text Key: 176518692
• Report Number: 1818910-2019-124770
• 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,Followup
• Report Date: 12/06/2019

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 Model Number: 2545-00-165
• Device Catalogue Number: 254500165
• Device Lot Number: NG76827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 12/20/2019; 01/27/2020
• Supplement Dates FDA Received: 01/14/2020; 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 109