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

Model Number	2107-1015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Broken the tip of omnifrex driver shaft, the broken part remained still in patient body.
Additional Manufacturer Narrative
An event regarding a fractured hexalobular screwdriver tip from a trident driver shaft was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection of the returned device shows hexalobular tip of screwdriver was fractured.The fractured piece was not included with the returned driver shaft.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 fracture consistent with a torsional overload.Medical records received and evaluation: a review of medical records was not performed as none were provided.No further information was requested as there is no indication the failure 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 01 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 was fractured.The fractured piece was not included with the returned driver shaft.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 fracture consistent with a torsional overload.
Event or Problem Description
Broken the tip of omnifrex driver shaft, the broken part remained still in patient body.

• Brand Name: UNIVERSAL DRIVER SHAFT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6564679
• Report Number: 0002249697-2017-01538
• Device Sequence Number: 18989386
• Product Code: LPH
• UDI-Device Identifier: 07613327212204
• UDI-Public: (01)07613327212204(11)161020(10)F11T11332
• Combination Product (Y/N): N
• PMA/510(K) Number: K153345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2017

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
• Operator of Device: Health Professional
• Device Model Number: 2107-1015
• Device Catalogue Number: 2107-1015
• Device Lot Number: F11T11332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Initial Date Received by Manufacturer: 04/17/2017
• Supplement Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 07/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other