MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI FEM FIN BLK SZ 5; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Model Number 2024-71-500

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2021

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

Chisel broke in cut block.Can¿t get the broken piece out of block.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned devices confirmed 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.

• Brand Name: SIGMA HP UNI FEM FIN BLK SZ 5
• Type of Device: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11217293
• MDR Text Key: 228479292
• Report Number: 1818910-2021-01706
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295083795
• UDI-Public: 10603295083795
• 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,Followup
• Report Date: 01/12/2021

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
• Device Operator: Health Professional
• Device Model Number: 2024-71-500
• Device Catalogue Number: 202471500
• Device Lot Number: A0709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 01/22/2021
• Supplement Dates Manufacturer Received: 01/15/2021; 02/10/2021
• Supplement Dates FDA Received: 01/29/2021; 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1