MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SIGMA HP DIS FEM BLK; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Model Number 9505-01-236

Device Problem Material Twisted/Bent (2981)

Patient Problem No Code Available (3191)

Event Date 10/22/2020

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

The primary surgery was performed on (b)(6) 2020 via tka for the patient's left knee joint.During the surgery, when the surgeon cut the distal femur, he had a difficulty cutting because the gap of slit to insert a blade was too extensive.The surgeon used a blade (1.27 mm thick and 19 mm wide).The surgery was completed with another device within 30 minutes delay.Duration of replacing the devise was wasting time.The surgeon commented that the thickness of the slit of the blade entry side and out side is different, and the slit near the center appears to be worn and extended by visual level.No further information is available.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned device could not confirm the reported event.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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

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.

• Brand Name: SIGMA HP DIS FEM BLK
• Type of Device: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10801901
• MDR Text Key: 215072942
• Report Number: 1818910-2020-24099
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295225416
• UDI-Public: 10603295225416
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9505-01-236
• Device Catalogue Number: 950501236
• Device Lot Number: SO2027588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2020
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1