MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SIG HP REV 4IN1 CUT BLK SZ3; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Catalog Number 201103002

Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919); Physical Resistance/Sticking (4012)

Patient Problem Not Applicable (3189)

Event Date 10/15/2019

Event Type  malfunction  

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 Description

It was reported that after inserting a headed pin through the tc3 4 in 1 block, the pin got struck through the block and distal spacer and could not be removed, both during and after the case.With 20 minutes surgical delay.

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 : examination of the returned device confirmed the reported event.The investigation findings did not indicate 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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIG HP REV 4IN1 CUT BLK SZ3
• Type of Device: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9297438
• MDR Text Key: 187202068
• Report Number: 1818910-2019-115293
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295081234
• UDI-Public: 10603295081234
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201103002
• Device Lot Number: SO2017051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR