MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL DRIVER SHAFT

Catalog Number 2107-1015

Device Problems Break (1069); Fracture (1260); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Attempted to implant the tha cap with a screw.There was damage to the tip of the screw driver that was left in the cap.The broken tip could not be removed out of the patients body and remained in the screw head.

Manufacturer Narrative

An event regarding a fractured hexalobular screwdriver tip from a trident driver 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.Deformation to the driver indicates the tip fractured while the device was being used to tighten a screw.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 have been 3 other events 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.Deformation to the driver indicates the tip fractured while the device was being used to tighten a screw.

Event Description

Attempted to implant the tha cap with a screw.There was damage to the tip of the screw driver that was left in the cap.The broken tip could not be removed out of the patients body and remained in the screw head.

• Brand Name: UNIVERSAL DRIVER SHAFT
• Type of Device: UNIVERSAL DRIVER SHAFT
• 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: 6087754
• MDR Text Key: 59836690
• Report Number: 0002249697-2016-03534
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

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: F7K15594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 11/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2012
• 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