MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 4 6MM; KNEE TIBIAL INSERT

Model Number	1517-10-406
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Primary surgery using attune revision implants (b)(6) 2020; surgeon trailed femoral tibial and insert and was satisfied with results.Implants opened tibial, femoral & patella implants cemented.Surgeon used a trial cr insert at this stage.A definitive revision insert opened, surgeon was unsuccessful at inserting and damaged the post area aspect of the polly.Ps insert was then opened and inserted.Surgeon instrument to insert definitive poly.
Event or Problem Description
Surgery was delayed for about 10-15 mins.
Additional 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.Added: b5, h6 patient code 3191 is used to capture surgery prolonged.
Additional Manufacturer Narrative
Product complaint # = > (b)(4) investigation summary = > the device associated with the reported event was not returned for evaluation.Examination of the provided photographs could not confirm the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot = > ¿ product code 151710406, attune crs rp insrt sz 4 6mm, work order 9037130 was manufactured on 24 january 2019 ¿ 12 parts were manufactured per specification, and all raw materials met the specification ¿ there were no non-conformances (ncs)/deviations/capas associated with this lot.¿ there were no mrrs (material review report) for reprocessing or scrap associated with this lot.H6 patient code: no code available (3191) used to capture the insufficient information.

• Brand Name: ATTUNE CRS RP INSRT SZ 4 6MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9788307
• Report Number: 1818910-2020-06862
• Device Sequence Number: 2457049
• Product Code: NJL
• UDI-Device Identifier: 10603295055792
• UDI-Public: 10603295055792
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/19/2020

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: 1517-10-406
• Device Catalogue Number: 151710406
• Device Lot Number: 9037130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 03/11/2020; 11/05/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 03/18/2020; 11/06/2020
• 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: UNK ATTUNE FEMORAL; UNK ATTUNE KNEE PATELLA; UNK ATTUNE KNEE TIBIAL TRAY