MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP2 SLOTTED TIB CUT BLK 3 DEG; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Model Number	96-6321
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Today, a patient surgery was scheduled at the (b)(6), in full surgery with an open patient the tibial cutting guide no.966321 number 3 did not enter the lane of the external cutting guide 966311.Despite several attempts, they failed to assemble.The surgeon had to make the cut by holding this guide freehand since he had no other option, he was with an open patient and unfortunately the cut went wrong.The surgery had an additional delay of approximately 01 hour and 15 minutes than usual.
Additional 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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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: product complaint (b)(4).Investigation summary: examination of the provided information could not confirm the reported event.Additional damage was found, however.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SP2 SLOTTED TIB CUT BLK 3 DEG
• Common Device Name: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9402337
• Report Number: 1818910-2019-119609
• Device Sequence Number: 1711380
• Product Code: HWA
• UDI-Device Identifier: 10603295247852
• UDI-Public: 10603295247852
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 96-6321
• Device Catalogue Number: 966321
• Device Lot Number: AR0814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 12/03/2019; 01/29/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 12/09/2019; 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1