MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REV TIBIAL VIEW PLT SZ5; KNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS

Model Number	2178-65-150
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2020
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.Investigation summary = > examination of the returned device confirmed the reported event.The damage is consistent with device use from normal use and servicing and the investigation did not indicate that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
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
It was reported that the instruments were found broken in spd and worn out/stripped.
Additional Manufacturer Narrative
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.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > examination of the returned device confirmed the reported event.The damage is consistent with device use from normal use and servicing and the investigation did not indicate that a broader investigation or corrective action was necessary.Corrected: h3.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The complaint sample consisted of (1) 217865150 mbt rev tibial view plt sz5.Examination of the returned mbt rev tibial view plt confirmed the reported breakage.The plate has broken into two pieces.All pieces of the device were returned.The overall condition of the instrument indicates multiple usages.The instrument exhibits burnishing wear indicated of extended usage.The device exhibits a shade of yellow indicating it has been subjected to numerous decontamination procedures.The root cause is being attributed to product damage through normal use and servicing.No corrective action is being taken based on the investigation determination of device damage from normal use and servicing as the root cause.Complaint trends will be monitored by post market surveillance through sep-419.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: MBT REV TIBIAL VIEW PLT SZ5
• Common Device Name: KNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9917084
• Report Number: 1818910-2020-10021
• Device Sequence Number: 11371986
• Product Code: LXH
• UDI-Device Identifier: 10603295096696
• UDI-Public: 10603295096696
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup,Followup
• Report Date (Section B): 03/16/2020

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: 2178-65-150
• Device Catalogue Number: 217865150
• Device Lot Number: SO2031972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 04/06/2020; 04/03/2020; 04/06/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 04/09/2020; 04/13/2020; 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1