MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL DRIVER SHAFT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 2107-1015

Device Problems Defective Component (2292); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2016

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Surgeon went to use the torx screwdriver and it was close to breaking so he asked that screwdriver be sent back.We then opened another one and used it and that screwdriver was also starting to twist.He said he would feel more comfortable if both screwdrivers were replaced.

Manufacturer Narrative

An event regarding damage (deformation) involving a trident driver shaft was reported.The event was confirmed.Visual inspection of the device confirms the reported event.The hexalobular driver tip is deformed.Material analysis was not required as the visual inspection was discussed with the material analysis engineer and further assessment was not required.Not performed as patient factors did not contribute to event.Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been 2 other events for the lot referenced.Visual inspection of the device confirms the reported event.The hexalobular driver tip is deformed.The deformation of the tip indicates that it was damaged while the device being used to tighten a screw.

Event Description

Surgeon went to use the torx screwdriver and it was close to breaking so he asked that screwdriver be sent back.We then opened another one and used it and that screwdriver was also starting to twist.He said he would feel more comfortable if both screwdrivers were replaced.

• Brand Name: UNIVERSAL DRIVER SHAFT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5900208
• MDR Text Key: 53839766
• Report Number: 0002249697-2016-02692
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2107-1015
• Device Lot Number: F10H85761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other