MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN TIB AUG UNIV SZ 5/6 5MM; KNEE TIBIAL TRAY ACCESSORY

Model Number	1523-05-001
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
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
Intraoperatively, during primary surgery left side, one screw of the augment could not be completely countersunk.Another augment was available and was fixed without any issue.No adverse patient impact, no surgery delay reported.
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.
Event or Problem Description
Additional information received indicated that the screw that should fix the augment to the femoral component did not sink in the augment's hole, but protruded.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned device found no evidence confirming the reported event.The investigation found no evidence of product malfunction or product error and the need for corrective action was not indicated.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.The investigation found no evidence of product error as a contributing factor to the reported event and the need for corrective action was not indicated.Device history lot : dhr review: 1) quantity manufactured: (b)(4).2) date of manufacture: 8/20/2019.3) any anomalies or deviations identified in dhr: na.4) expiry date: 7/31/2029.5) ifu reference: 090200873 rev b.

• Brand Name: ATUN TIB AUG UNIV SZ 5/6 5MM
• Common Device Name: KNEE TIBIAL TRAY ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11757312
• Report Number: 1818910-2021-09354
• Device Sequence Number: 3526940
• Product Code: NJL
• UDI-Device Identifier: 10603295057598
• UDI-Public: 10603295057598
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 04/15/2021

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: 1523-05-001
• Device Catalogue Number: 152305001
• Device Lot Number: J47H73
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 06/07/2021; 06/24/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/18/2021; 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATUNE REV RP TIB BASE SZ 5 CEM