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

Model Number	2545-01-048
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
Additional 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
• Common Device Name: ATTUNE INSTRUMENTS : PATELLA TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10466577
• Report Number: 1818910-2020-19006
• Device Sequence Number: 2890357
• Product Code: HWT
• UDI-Device Identifier: 10603295395515
• UDI-Public: 10603295395515
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 2545-01-048
• Device Catalogue Number: 254501048
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 09/02/2020; 09/22/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 09/08/2020; 09/23/2020
• Patient Sequence Number: 1