MAUDE Adverse Event Report: STRYKER GMBH K-WIRE, S.S. DRILL POINT RINGFIX Ø1.8MM (.070") X 400MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 4513003

Device Problem Detachment Of Device Component (1104)

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

Event Date 11/22/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device will not be returned.If additional information becomes available it will be provided on a supplemental report.The device is not available to stryker.

Event Description

One olive and several smooth wires were passing poorly through the patients mid tibia.Two of which lost their tips in the patient's tibia.Upon x-ray, the wires showed a burned-like tip, without the drill tip.

• Brand Name: K-WIRE, S.S. DRILL POINT RINGFIX Ø1.8MM (.070") X 400MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5328844
• MDR Text Key: 35016822
• Report Number: 0008031020-2015-00648
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 4513003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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