MAUDE Adverse Event Report: DEPUY SYNTHES 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	03/04/2019
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
Surgeon was using the view plate to ream through to make sure he was centered.Reamed up and then didn't remove it before the proximal reamer and it cracked and broke the view plate.Also, spd noticed when they were putting the set back together that the other plate was cracked.Unsure of when that happened was surgery delayed due to the reported event? --> no, action taken when event occurred? --> removed broken 2 pieces and moved on, was procedure successfully completed? --> yes, were fragments generated? --> no, if yes, were they removed easily without additional intervention? --> yes, if no, explain --> perfect break in two, patient status/ outcome / consequences --> no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, is the patient part of a clinical study --> no, activity level --> unknown, (b)(4).Device property of -->hospital, device in possession of -->spd, (b)(4).Device property of -->hospital, device in possession of -->(b)(6).By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.--> true.
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 view plate confirmed the reported event.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 will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.

• Brand Name: MBT REV TIBIAL VIEW PLT SZ3
• Common Device Name: KNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS
• Manufacturer (Section D): DEPUY SYNTHES; 1210 ward avenue; west chester PA 19380 XXXX
• MDR Report Key: 8444837
• Report Number: 1818910-2019-88215
• Device Sequence Number: 16593116
• Product Code: LXH
• UDI-Device Identifier: 10603295096672
• UDI-Public: 10603295096672
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 03/04/2019

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: SO2022188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/25/2019; 04/18/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 03/27/2019; 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 100