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

Catalog Number 2107-1015

Device Problems 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 02/13/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Surgeon was using a torx screwdriver when the tip broke off.

Manufacturer Narrative

An event regarding damage involving a trident driver shaft was reported.The event was confirmed.Method and results: -device evaluation and results: the universal driver shaft was returned in used condition.The hexalobular tip of screwdriver shaft was damaged.The deformation to the driver indicates the tip was deformed while the device was being used to tighten a screw.Material analysis is not required for the universal driver shaft as it falls in the scope of a capa.- medical records received and evaluation: a review of medical records was not performed because no medical records or x-rays were made available for evaluation.No further information was requested as there is no evidence to support the event was related to patient factors.-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 1 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 damaged.The deformation to the driver indicates the tip was deformed while the device was being used to tighten a screw.Material analysis is not required for the universal driver shaft as it falls in the scope of a capa.

Event Description

Surgeon was using a torx screwdriver when the tip broke off.

• 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: 6397092
• MDR Text Key: 69994568
• Report Number: 0002249697-2017-00862
• 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: 05/24/2017

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: F11L10963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2017
• Initial Date FDA Received: 03/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2016
• 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