MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. QUICKSET TPRD HEX SCDR U-JOINT; HIP INSTRUMENT/TRIAL

Catalog Number 227463000

Device Problem Failure to Disconnect (2541)

Patient Problem No Information (3190)

Event Date 10/14/2015

Event Type  malfunction  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(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

Engagement of the modified universal hex screwdriver into the cancellous screw got stuck upon insertion when placing the screw into the cup.The screw required removal and new one implanted.

Manufacturer Narrative

Conclusion and justification status for mdr: the reported incident could not be confirmed as no products were received for investigation.However, multiple complaints have been received for stripped drivers, fractured hex drivers, and for the hex drivers cold welding to the screws.Originally, data was reviewed under the root cause investigation (b)(4).It was determined as a result of the investigation to conduct a preliminary risk assessment.(b)(4) was conducted in april 2015 and determined that there had been no increase in patient harm and that the severity and occurrence of the various failure modes resulted in broadly acceptable risks.Thus, no action was to be taken regarding cold-welding or stripping failures on codes 227449000, 227463000, 227447000, 227448000.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.

• Brand Name: QUICKSET TPRD HEX SCDR U-JOINT
• Type of Device: HIP INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5273342
• MDR Text Key: 32882581
• Report Number: 1818910-2015-36852
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 227463000
• Device Lot Number: NOT KNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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