MAUDE Adverse Event Report: DEPUY IRELAND 9616671 TRUMATCH ATTUNE KIT LEFT; TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES

Catalog Number	420945
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2017
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
It was reported that one of the arms from the tibial cutting block broke while surgeon was cutting the proximal tibia.Both pieces were retrieved and it did not extend the case time.
Additional Manufacturer Narrative
Product complaint: (b)(4).Investigation summary: the device associated with this complaint was not returned.Photographic evidence confirmed the reported event.Dhr reviewed, no deviations or non-conformance's were noted.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TRUMATCH ATTUNE KIT LEFT
• Common Device Name: TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• MDR Report Key: 7141676
• Report Number: 1818910-2017-52396
• Device Sequence Number: 16378704
• Product Code: NJL
• UDI-Device Identifier: 10603295431794
• UDI-Public: 10603295431794
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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: 420945
• Device Lot Number: 088SE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR