MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SIG HP REV 4IN1 CUT BLK SZ4; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Model Number	2011-03-003
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2020
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 the screw will not pass through screw hole in size 4, 4-in-1 cutting block and notch cutting guide.No surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary examination of the returned device confirmed the reported event.The investigation did not establish that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative:.

• Brand Name: SIG HP REV 4IN1 CUT BLK SZ4
• Common Device Name: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10309034
• Report Number: 1818910-2020-16539
• Device Sequence Number: 3416987
• Product Code: HTZ
• UDI-Device Identifier: 10603295081241
• UDI-Public: 10603295081241
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 07/14/2020

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: 2011-03-003
• Device Catalogue Number: 201103003
• Device Lot Number: SO2034031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1