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); Detachment Of Device Component (1104); 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 01/18/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Tip broke off screwdriver shaft.Surgeon used other screwdriver shafts to complete case.

Manufacturer Narrative

An event regarding an alleged fractured trident driver shaft was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection indicated that the hexalobular driver tip is fractured; deformation to the driver indicates the tip fractured while the device was being used to tighten a screw.Medical records received and evaluation: "unable to confirm event description as not confirmed in op report, no evidence of any complication resulting or fracture screwdriver shafts." device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: there has been one other event for this lot.Conclusions: visual inspection of the returned device revealed the hexalobular driver tip is deformed (fractured).The root cause was determined to be application of excessive force by the user.

Event Description

Tip broke off screwdriver shaft.Surgeon used other screwdriver shafts to complete case.

• 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: 5454714
• MDR Text Key: 39230996
• Report Number: 0002249697-2016-00418
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151264
• 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: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• 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: F10L85861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/11/2015
• 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
• Patient Age: 73 YR