MAUDE Adverse Event Report: STRYKER TRAUMA KIEL GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA Ø3X800 MM; INSTRUMENT

Catalog Number 18060080S

Device Problem Break (1069)

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

Event Date 12/17/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Pharmacist at the hospital, reported the following event : "during use, the guide was damaged in the tibia with the formation of metallic chips within it." no delay and no adverse consequences were reported by the customer.

Manufacturer Narrative

The evaluation revealed the guide wire to be the primary product.No deviations were found during review of the manufacturing and inspection documents (dhr).The wire returned was documented as faultless prior to distribution.During investigation no material, dimension, design or manufacturing related issues were found.The wire shaft was found heavily deformed approx.From the middle towards the tip.At the beginning of the deformation an im reamer abraded the shaft material and cut a deep track into the shaft; material got abraded and was buckled to burrs.Metal chips got stuck on the surface.Scratches on the surface behind the cut-damaged area indicate that the guide wire was used successfully with im reamers before.The abrasion of the shaft material was only possible because the guide wire was heavily deformed.The wire was used with reamers prior to the damage successfully.It is unclear whether the reamer was used in the same surgery or in previous surgeries multiple times.Deforming the wire is not intended and not necessary for reaming process, furthermore the wire is labeled as single use device.The ifu includes that modifying of the design of any instrument is not allowed, furthermore all instruments shall be checked prior every surgery.Single use items shall not be reused.Because no manufacturer related issues were found the case is attributed to the user (use error).Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.

Event Description

Pharmacist at the hospital, reported the following event: "during use, the guide was damaged in the tibia with the formation of mettalic chips within it." no delay and no adverse consequences were reported by the customer.

• Brand Name: GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA Ø3X800 MM
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6257399
• MDR Text Key: 65464128
• Report Number: 0009610622-2017-00022
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 18060080S
• Device Lot Number: K0EB3E5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2016
• 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