MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFCSIGMA POST FEM AUG TRL8MMS5; KNEE INSTRUMENT : FEMORAL TRIALS

Catalog Number	961908
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2019
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
(2) instruments found in set broken.Did the patient experience a post-op device malfunction? --> no.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? --> no.Did the patient require revision surgery or hardware removal? --> no.If no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions? --> no.Patient status/ outcome / consequences --> no.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint (b)(4).Investigation summary: examination of the returned device confirmed the reported event.The investigation attributed the root cause to unintended user error.The investigation did not indicate that a broader investigation or corrective action was necessary.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFCSIGMA POST FEM AUG TRL8MMS5
• Common Device Name: KNEE INSTRUMENT : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8775707
• Report Number: 1818910-2019-97916
• Device Sequence Number: 1889955
• Product Code: LXH
• UDI-Device Identifier: 10603295240464
• UDI-Public: 10603295240464
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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 Catalogue Number: 961908
• Device Lot Number: D1296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1