MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI TIB CUT BLK RM/LL; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Model Number 2024-40-200

Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2018

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

Intraoperatively it was not possible to separate the both instruments.No surgical delay, no adverse consequences for patient.Another instrument was available and used without any issues.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.Depuy considers the investigation closed at this time.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: SIGMA HP UNI TIB CUT BLK RM/LL
• Type of Device: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9401306
• MDR Text Key: 168931061
• Report Number: 1818910-2019-119511
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295082989
• UDI-Public: 10603295082989
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2024-40-200
• Device Catalogue Number: 202440200
• Device Lot Number: SO2030806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1