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

Catalog Number 2107-1015

Device Problems Bent (1059); Break (1069); 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 02/22/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Sales rep reported that the surgeon was placing screw in acetabular cup and noticed tip of screwdriver was bent and stripped.

Manufacturer Narrative

An event regarding damage (bent and stripped) involving a trident driver shaft was reported.The event was confirmed.Method & results: -device evaluation and results: the universal driver shaft was returned in used condition.The hexalobular tip of screwdriver shaft was bent and stripped.The deformation to the driver indicates the tip was deformed while the device was being used to tighten a screw.Examination of the returned device with material analysis engineer indicated the damage observed is consistent with in-service use.-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 has been no other event for the lot referenced.Conclusions: the reported event was confirmed as per visual inspection of the returned device which shows that the hexalobular tip of screwdriver shaft was bent and stripped.The deformation to the driver indicates the tip was deformed while the device was being used to tighten a screw.Examination of the returned device with material analysis engineer indicated the damage observed is consistent with in-service use.A capa was performed an investigation into reports of fractured trident driver tips.The investigation found that the failure mode is observed when the driver is over torqued, the driver tip wears excessively due to repeated use of the driver, or when the driver tip is angulated extremely within the screw head during use.An ecn was implemented on may 6, 2005 to improve the fit of the driver tip and screw head and reduce the likelihood of driver tip deformation.Although the design was improved, the results of the design validation testing indicated that the tip remained susceptible to deformation at extreme angulations of the driver tip within the screw head.The design intent of the driver tip is to deform rather than to deform and/or break the screw (implant).

Event Description

Sales rep reported that the surgeon was placing screw in acetabular cup and noticed tip of screwdriver was bent and stripped.

• 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: 6423080
• MDR Text Key: 70701864
• Report Number: 0002249697-2017-00979
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• 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: F6M11646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2011
• 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