MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIG HP REV 5IN1 CUT BLK SZ4; KNEE INSTRUMENT/TRIAL

Catalog Number 201103003

Device Problems Disassembly (1168); Difficult to Remove (1528); Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 07/10/2017

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.

Event Description

It was reported that a headed pin got stuck inside a size 4 hp revision 4 in 1 cutting block with 8 mm augment on it.Pulled pin from bone with plyers.

Manufacturer Narrative

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

• Brand Name: SIG HP REV 5IN1 CUT BLK SZ4
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6773200
• MDR Text Key: 82019937
• Report Number: 1818910-2017-22324
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295081241
• UDI-Public: 10603295081241
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/10/2017

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: 201103003
• Device Lot Number: SO2008645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2017
• Initial Date FDA Received: 08/08/2017
• Supplement Dates Manufacturer Received: 08/28/2017
• Supplement Dates FDA Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2013
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1