MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SP2 SLOTTED TIB CUT BLK 3 DEG; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Catalog Number 966321

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2019

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

Upon entering the surgery it is evident that the extramedullary guide of tibia was split piece and tighten the cutting guide n3.The equipment was delivered.During the procedure, an attempt was made to dismantle, but when the safety was broken, it was impossible.

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: product complaint # (b)(4).Investigation summary no device was received for examination, therefore the reported event could not be confirmed.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 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, a follow-up medwatch will be filed as appropriate.

• Brand Name: SP2 SLOTTED TIB CUT BLK 3 DEG
• Type of Device: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8347329
• MDR Text Key: 136614334
• Report Number: 1818910-2019-84838
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295247852
• UDI-Public: 10603295247852
• Combination Product (y/n): N
• 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: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 966321
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2019
• Patient Sequence Number: 1