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 Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After screw implantation the screwdriver could not be disconnected from the screw head.Screw had to be explanted to be able to disconnect with lots of effort.It seems that the hex cut of the screwdriver does not perfectly match the screw head although/or even because it's a new one.No affect to patient.

Manufacturer Narrative

Depuy still 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.

Manufacturer Narrative

Conclusion and justification status: the customer reports after screw implantation the screwdriver could not be disconnected from the screw head.Screw had to be explanted to be able to disconnect with lots of effort.It seems that the hex cut of the screwdriver does not perfectly match the screw head although/or even because it's a new one.The reported incident could not be confirmed as no products were returned 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.The investigation could not draw any conclusions about the current reported event without the devices to examine.Based on the inability to determine a root cause, a need for corrective action is not indicated.Addendum added 16 feb 2016: the complaint was reopened as the products were returned.Upon inspection the failure mode was confirmed as reported.The returned product was assessed by bioengineering and a report was received stating whilst the complaint may be justified, the failure mode has been investigated and reviewed previously with no further actions recommended.No clear design or manufacturing issues were identified the complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Post market surveillance is per sep-419 depuy still 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: 5436214
• MDR Text Key: 38764002
• Report Number: 1818910-2016-13244
• 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,Followup
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2016
• 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: A1010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2010
• 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