MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI TIB CUT BLK LM/RL; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Model Number 2024-40-100

Device Problems Device Damaged by Another Device (2915); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2019

Event Type  malfunction  

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 Description

It was reported that the during post cleaning inspection the sizing arm was found to had been bent and the 2 cut blocks had gouges across the top.No surgical delay.

Manufacturer Narrative

Product complaint # : (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.Added; d10 corrected: h3 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.H10 additional narrative: corrected:h6,h6(device) product complaint #
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> (b)(4) investigation summary
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> examination of the returned device revealed evidence confirming the reported damage.The noted damage is consistent with device wear out through heavy high cycle usage in the field and the investigation did not establish a need for corrective action.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 device history lot
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> null device history batch
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> null device history review
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> null if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA HP UNI TIB CUT BLK LM/RL
• 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: 9491802
• MDR Text Key: 173336211
• Report Number: 1818910-2019-123963
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295082972
• UDI-Public: 10603295082972
• 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: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2024-40-100
• Device Catalogue Number: 202440100
• Device Lot Number: A0609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Date Manufacturer Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1