MAUDE Adverse Event Report: STRYKER GMBH CANNULATED T7 DRIVER SHAFT, QC FITTING AUTOFIX 2.0/2.5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number 9011017

Device Problems Crack (1135); Particulates (1451)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2013

Event Type  malfunction  

Manufacturer Narrative

With guidance from the mdr policy branch of the fda, mdr reported by stryker (b)(4) as a result of a retrospective lookback of complaints resulting from the acquisition of assets from (b)(4).Device will not be returned.If additional information becomes available it will be provided on a supplemental report.The reported device was manufactured and distributed by (b)(4), howmedica osteonics corp.¿s purchased certain assets of (b)(4) on august 1, 2014.Stryker became legal manufacturer of this product on april 1, 2015 and has taken the responsibility for medical device reporting.Device is not available to stryker.

Event Description

Driver shaft cracked and tip broke off during surgery.After interviewing rep it is believed the breakage was contributed to by utilizing a damaged driver.Surgeon was not satisfied with the reduction in joint & determined a revision was required.After revision in "flouro" indicated some shiny particulate - rep believes surgeon countersunk too deep, possibly causing some thread sheering resulting in some minor thread artifacts to be left behind.Rep does not feel that this shiny particulate is from the broken driver tip.

Event Description

Driver shaft cracked and tip broke off during surgery.After interviewing rep it is believed the breakage was contributed to by utilizing a damaged driver.Surgeon was not satisfied with the reduction in joint & determined a revision was required.After revision in ¿flouro¿ indicated some shiny particulate ¿ rep believes surgeon countersunk too deep, possibly causing some thread sheering resulting in some minor thread artifacts to be left behind.Rep does not feel that this shiny particulate is from the broken driver tip.

• Brand Name: CANNULATED T7 DRIVER SHAFT, QC FITTING AUTOFIX 2.0/2.5
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5318657
• MDR Text Key: 34806747
• Report Number: 0008031020-2015-00598
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9011017
• Device Lot Number: P1619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other