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

Catalog Number 966115

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem Not Applicable (3189)

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device is an instrument and is not implanted/explanted.

Event Description

When the surgeon tried to put the blade through the slot on the sp2 femoral cutting block, it was hard to get the blade through smoothly.It was reported as tight unevenly through the cutting slot.They tired a different blade with the same result.It was then established that it must be the cutting block which may be at fault.Looking at the cutting block afterwards, the rep could see that the metal surfaces on the cutting slot were burred.The procedure could be continued with this cutting block, it just made it harder than would be expected.Patient outcome was successful.The desired outcome was achieved.2-3 minutes delay in the procedure.

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.Product complaint #: (b)(4).Investigation summary: examination of the photos and device confirmed the failure mode as reported.The devices reviewed by depuy melbourne engineering and the root cause was determined to be due to the device being used from normal use and servicing.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.

• Type of Device: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8342819
• MDR Text Key: 136259158
• Report Number: 1818910-2019-84649
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 10603295246862
• UDI-Public: 10603295246862
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/28/2019

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 Catalogue Number: 966115
• Device Lot Number: NB6861
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/15/2019
• Supplement Dates Manufacturer Received: 04/26/2019
• Supplement Dates FDA Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1