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

Catalog Number 2107-1015

Device Problems Material Deformation (2976); Material Integrity Problem (2978); Material Twisted/Bent (2981)

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

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Doctor went to insert a screw and the screwdriver was starting to twist and he didn't feel safe using it.There was another screwdriver in the tray that was also twisted so we ended up getting him a new torx screwdriver.

Manufacturer Narrative

An event regarding damage (deformation) involving a trident driver shaft was reported.The event was confirmed.Method & results: -device evaluation and results: 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.-medical records received and evaluation: not performed as patient factors did not contribute to event.-device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been 02 other events for the lot referenced regarding damage to the hexalobular driver tip.Conclusions: visual inspection confirms the reported event which shows that 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.The returned device was consulted with material analysis engineer, concluded that the damage observed is consistent with in-service use.

Event Description

Doctor went to insert a screw and the screwdriver was starting to twist and he didn't feel safe using it.There was another screwdriver in the tray that was also twisted so we ended up getting him a new torx screwdriver.

• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6117878
• MDR Text Key: 60854866
• Report Number: 0002249697-2016-03700
• 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: 01/17/2017

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: 2107-1015
• Device Lot Number: F10H85761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/17/2017
• 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