MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP*2 DISTAL FEM CUTTING BLOCK; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Model Number 96-6115

Device Problem Device-Device Incompatibility (2919)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 04/27/2020

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

Match issue.It was reported that during the pfc operation, noted 966112 could not pass the way through the slot/hole of 966115.No back-up tools on the site, the surgeon cut the bone in according to his experiences.The surgery delayed about 40mins.The patient is stable and in hospital now.These two tools were 1st time use.

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.H10 additional narrative: added: e1 (facility name) corrected: h6 (patient) h6 patient code: no code available (3191) was used to capture prolonged surgery and insufficient information.

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned device confirms the reported event.Root cause and corrective action are documented in the capa system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• 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: 10044845
• MDR Text Key: 190615640
• Report Number: 1818910-2020-11966
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 10603295246862
• UDI-Public: 10603295246862
• Combination Product (y/n): N
• PMA/PMN Number: K043223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96-6115
• Device Catalogue Number: 966115
• Device Lot Number: SO2040602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1