MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFCSIGMA POST FEMAUG TRL4MM S4; KNEE INSTRUMENT : FEMORAL TRIALS

Model Number	96-1886
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
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
Two damaged items at (b)(6) hospital: damaged posterior augment ref (b)(4) ¿ no longer sits in femoral trial securely.Worn femoral punch ref (b)(4) ¿ distal tip is mis-shapen and worn down and no longer fit for purpose.Identified by (b)(6).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device was received for examination.Therefore, the reported event could not be confirmed.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: a manufacturing record evaluation (mre) was not possible, because the required lot code was not provided.
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.H10 additional narrative:  added: b3, b5, h6 (medical device problem code).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 a small plug on augment did not sit securely into the femoral trial and seemed loose or more susceptible to falling off.The "v" of the extractor tip was worn down and disfigured.

• Brand Name: PFCSIGMA POST FEMAUG TRL4MM S4
• Common Device Name: KNEE INSTRUMENT : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12554267
• Report Number: 1818910-2021-21549
• Device Sequence Number: 4080340
• Product Code: HWT
• UDI-Device Identifier: 10603295240396
• UDI-Public: 10603295240396
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/23/2021

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: 96-1886
• Device Catalogue Number: 961886
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 09/30/2021; 10/25/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 10/05/2021; 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1