MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRUMATCH ATTUNE KIT RIGHT; TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES

Catalog Number	420946
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2018
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 a case that was designed with different tibia resection from surgeons surgical preferences, due to a system glitch.The proposal was not designed to surgeon preferences but was approved by the surgeon.Surgery has not taken place but is scheduled for monday (b)(6) 2018.The sales rep and surgeon are aware of the resection change and will adjust resection cuts intraoperatively.
Additional Manufacturer Narrative
(b)(4).Investigation summary an investigation confirmed the reported event.The root cause has been identified and corrective action has been implemented.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot 095en device history review dhr reviewed no deviations or nonconformamces 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 RIGHT
• Common Device Name: TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7869945
• Report Number: 1818910-2018-69180
• Device Sequence Number: 1719768
• Product Code: JWH
• UDI-Device Identifier: 10603295431800
• UDI-Public: 10603295431800
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2018

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: 420946
• Device Lot Number: 095EN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1