MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MED DOM PAT DR TRL 29MM; ATTUNE INSTRUMENTS : PATELLA TRIALS

Model Number 2545-01-048

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Code Available (3191)

Event Date 07/31/2020

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

The connection between the attune patella drill clamp (2545-01-055) and the medialized dome patella drill trial (e.G., 2545-01-048) was not as stable as required.The drill trial repeatedly slipped off the drill clamp upon squeezing the drill clamp.The issue was circumvented by manually stabilizing the drill trial on the drill clamp upon squeezing the drill clamp.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE MED DOM PAT DR TRL 29MM
• Type of Device: ATTUNE INSTRUMENTS : PATELLA TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10466577
• MDR Text Key: 204748549
• Report Number: 1818910-2020-19006
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295395515
• UDI-Public: 10603295395515
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2020

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: 2545-01-048
• Device Catalogue Number: 254501048
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 09/02/2020; 09/22/2020
• Supplement Dates FDA Received: 09/08/2020; 09/23/2020
• Patient Sequence Number: 1