MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE RP CR ARTIC SURF SZ4; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Model Number	2545-00-564
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/02/2020
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
Attune cr tray would not accept spacer.Spring or bushing is damaged.
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.H6 patient code: no code available (3191) used to capture prolonged surgery and insufficient information.Corrected: h6 device code- damaged - unspecified is being retracted as additional information indicates spring was deformed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was stated that there was a surgery delay of 3 minutes.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary :the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: ATTUNE RP CR ARTIC SURF SZ4
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10148175
• Report Number: 1818910-2020-13704
• Device Sequence Number: 2050722
• Product Code: JWH
• UDI-Device Identifier: 10603295133049
• UDI-Public: 10603295133049
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2020

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: 2545-00-564
• Device Catalogue Number: 254500564
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 06/10/2020; 07/21/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 06/16/2020; 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1