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

Model Number	1806-0090S
Medical Device Problem Codes	Break (1069); Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The customer reported that: "the rod got stuck in the reamer (diameter 8) and broke off at the end.Change of rod and reamer size because the spare reamer of the same size was in autoclave.The device could be recovered.".
Event or Problem Description
The customer reported that: "the rod got stuck in the reamer (diameter 8) and broke off at the end.Change of rod and reamer size because the spare reamer of the same size was in autoclave.The device could be recovered.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the guide wire is broken as complained.The device inspection revealed the following: the visual inspection has shown that piece of about 27mm length is broken off.The fragment was not received for evaluation, but it is visible on the provided picture.In general is the guide wire is in a very used condition, there are stress marks, nicks and deformations all over the device visible.Especially in the area of the fracture are very strong stress marks visible.There is also a notch above the fracture face visible, this notch indicates that the reamer did cut into the wire, which indicates that the wire was deformed in this area during use.The fracture has the view of a ductile overload fracture, where first a permanent distortion with a subsequent fracture occurred.The visible colors indicate that there was very high temperature, caused by friction between the reamer and the rod, before the device broke.The relevant dimension was verified during the investigation and no deviation from the specification could be detected.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.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by a deformation of the guide wire, this deformation did lead to high friction between the reamer and the wire, this friction did damage the surface of the devices which finally caused the jamming of the reamer and the subsequent breakage of the guide wire.If more information is provided, the case will be reassessed.

• Brand Name: GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 TIBIA Ø3X800 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13596017
• Report Number: 0009610622-2022-00070
• Device Sequence Number: 5833854
• Product Code: LXH
• UDI-Device Identifier: 04546540195951
• UDI-Public: 04546540195951
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: 1806-0090S
• Device Catalogue Number: 18060090S
• Device Lot Number: K021211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown