MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PROXIMAL TIBIAL RESECT GUIDE; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Model Number	2490-46-000
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2020
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
Dragon tooth tibia.Slot where slap hammer attaches must have a burr as it doesn't release easily.Released when tapped with mallet.7 degree cutting block.One of the holes doesn't accept pin.Must be burred.Picked a different hole which accepted the pin.No adverse events to report.Occurred during surgery.Rep present.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the returned instrument was assessed by depuy australia and the complainants findings confirmed.The assessment was that the complaint was due to wear and tear.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H10 additional narrative: added: e1.

• Brand Name: PROXIMAL TIBIAL RESECT GUIDE
• Common Device Name: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10143830
• Report Number: 1818910-2020-13645
• Device Sequence Number: 2911659
• Product Code: HWT
• UDI-Device Identifier: 10603295125884
• UDI-Public: 10603295125884
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2020

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: 2490-46-000
• Device Catalogue Number: 249046000
• Device Lot Number: J0206
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 06/25/2020; 07/17/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 06/28/2020; 07/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1