MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 TRUMATCH CT CUT GUIDE KIT R; TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES

Model Number	420916
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/06/2020
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 trumatch tibial cutting block plastic was broken during the initial phase of cutting of the tibial plateau.The trumatch cutting block was removed and the tradition attune tib cutting block was placed to guide the remainder of the cut.The case was maybe delayed 1 minute.No additional adverse events followed and the case went on smoothly.
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.
Event or Problem Description
It was reported that the 1.19 saw blade thickness was used.
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 : the device associated with this report was not returned for evaluation.No evidence was found indicating product error was a contributing factor to the reported event.Information concerning the saw blade used during the surgery confirmed that the surgeon used a non-recommended blade.The root cause is user error/misuse/off label use by using a non-recommended saw blade.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : 20996.Device history batch : null.Device history review : the review found one non-conformance (b)(4) against the provided lot number.The nr was for a batch of resin not meeting a material specification, and it is not related to the current reported event.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TRUMATCH CT CUT GUIDE KIT R
• Common Device Name: TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9603816
• Report Number: 1818910-2020-02213
• Device Sequence Number: 2500827
• Product Code: FSM
• UDI-Device Identifier: 10603295384861
• UDI-Public: 10603295384861
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 01/06/2020

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: 420916
• Device Catalogue Number: 420916
• Device Lot Number: 20996
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 01/21/2020; 01/28/2020
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 02/06/2020; 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR