MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MBT REV TIBIAL VIEW PLT SZ3; KNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS

Catalog Number	217865130
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2019
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
T was reported that while retrieving the sizing plate off of the tibia, the plate was found to be broken in half.All pieces were retrieved.Well using the spiked handle to take out the plastic pieces for the argument.The speak piece became lodged in the plastic.The plastic container in the small sharp portion was thrown in the trashcan.The handle was being returned.No surgical delay.
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.Product complaint (b)(4).Investigation summary: examination of the returned view plate confirmed the reported event the device has broken into two pieces.The noted damage is consistent with device use from normal use and servicing and the investigation did not establish a need for corrective action.Depuy considers the investigation closed.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: MBT REV TIBIAL VIEW PLT SZ3
• Common Device Name: KNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8785172
• Report Number: 1818910-2019-98173
• Device Sequence Number: 2360033
• Product Code: LXH
• UDI-Device Identifier: 10603295096672
• UDI-Public: 10603295096672
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 06/21/2019

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: 217865130
• Device Lot Number: SO2001684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR