MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SM TORQUE LIMITING DRIVER; TORQUE DEVICES

Catalog Number 214118001

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

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

It was reported that the screwdriver top loosens up when used.

Manufacturer Narrative

This product was reported in error.It was determined that this electronic complaint record was recorded for competitor product that was not manufactured and/or distributed by depuy synthes.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: SM TORQUE LIMITING DRIVER
• Type of Device: TORQUE DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10426385
• MDR Text Key: 204528765
• Report Number: 1818910-2020-18371
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

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: 214118001
• Device Lot Number: BV657647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 09/14/2020
• Supplement Dates FDA Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1