MAUDE Adverse Event Report: STRYKER GMBH K-WIRE Ø3.2 X 150MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 703954S

Device Problem Flaked (1246)

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

Event Date 03/06/2015

Event Type  malfunction  

Event Description

The customer, has reported via the sales rep.That during matta pelvic 2 surgery, metal flakes allegedly came off three kwires size 3.2x150mm (b)(4).The sales rep has reported that the surgeon was using this kwire to hold the matta pelvic pro retractors.The sales rep has reported that the wound was washed out and that the surgery was completed as normal.

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Manufacturer Narrative

The reported incident that k-wire ø3.2 x 150mm was alleged of following issue ¿metal flakes allegedly came off three k wires¿ could not be confirmed.Based on investigation, the root cause was attributed to a user related issue.The device inspection revealed the following: slight scratches on the surface of the k-wires.Metal flakes and major damages of the k-wires have not been identified.Scratches on the k-wire surface can be caused while inserting by a wrong angulation of the k-wire with the retractor.Rotation of the retractor over the inserted k-wires can lead to scratches and damages on the k-wire surface.Those damages can be prevented as described in operative technique (pro-st-1-en_rev-1_pro pelvis operative technique_2015-6912): ¿retractor 3 originally designed to retract the iliac vessels, retractor 3 is equipped with a light pipe attachment and 2 k-wires to hold the retractor in place and prevent rotation.Retractor 3 may be the most ideal for light pipe attachment.¿ a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

Event Description

The customer, has reported via the sales rep.That during matta pelvic 2 surgery, metal flakes allegedly came off three kwires size 3.2x150mm ((b)(4)).The sales rep has reported that the surgeon was using this kwire to hold the matta pelvic pro retractors.The sales rep has reported that the wound was washed out and that the surgery was completed as normal.

• Brand Name: K-WIRE Ø3.2 X 150MM
• 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: 4651474
• MDR Text Key: 5596358
• Report Number: 0008031020-2015-00122
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2015

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: 703954S
• Device Lot Number: K078A0A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2015
• Initial Date FDA Received: 04/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other