MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG CRVD+ INS TRL 3 8MM; KNEE INSTRUMENT : TIBIAL TRIALS

Model Number	97-2350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/21/2020
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
It was reported that the trial poly left tiny pieces behind in patient.Another trial was used for cementing and the case proceeded as planned.A delay of 1 minute in surgery.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary : examination of the returned device could not confirm the reported event, but did identify the insert trial exhibits significant scratching and gouging on the articulating surface.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H6 component code: part/component/sub-assembly term not applicable (g07001) used to capture visual: scratched/nicked corrected:.
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 was received stating that there were tiny shavings off of the poly trial in the patient.More than 2 pieces.It was believed that all was removed.

• Brand Name: SIG CRVD+ INS TRL 3 8MM
• Common Device Name: KNEE INSTRUMENT : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10792301
• Report Number: 1818910-2020-24009
• Device Sequence Number: 11580030
• Product Code: LXH
• UDI-Device Identifier: 10603295251095
• UDI-Public: 10603295251095
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2020

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: 97-2350
• Device Catalogue Number: 972350
• Device Lot Number: BFI1B32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2020
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 10/31/2020; 11/30/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 11/12/2020; 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR