MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA STAB XLK INS 2.5 8MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-22-108
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	10/02/2019
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
A tibial insert shape was modified, it could not be impacted, therefore it was not implanted.Patient status, outcome, consequences: no.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the product was returned and forwarded on to the manufacturing site in cork for review.A worldwide complaint database search found no other reported incidents against the provided product / lot combinations since release for distribution.The investigation report from the manufacturing site summarised: a device history record review was conducted and the returned product was examined for the defect.The complaint was confirmed.Due to a missed inspection the failure mode of ¿burr¿ has been confirmed.There is no patient risk as the affected part was not implanted.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.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA STAB XLK INS 2.5 8MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9284278
• Report Number: 1818910-2019-114394
• Device Sequence Number: 1934631
• Product Code: JWH
• UDI-Device Identifier: 10603295064169
• UDI-Public: 10603295064169
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2019

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: 1581-22-108
• Device Catalogue Number: 158122108
• Device Lot Number: 9165598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 12/03/2019; 04/15/2020
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 12/10/2019; 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1