MAUDE Adverse Event Report: STRYKER TRAUMA KIEL GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 HUMERUS Ø2,2X800 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0093S
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "management of a fracture of the left humerus, placement of the stryker reduction guide.Attempt to insert a rigid stryker nail.The surgical team noticed an unusual and unexpected deformation of the nailing guide, which caused the nail to jam.As a result, the surgeon changed the method and performed an elastic nailing osteosynthesis of the metaizeau type".Additionally there was a 45 minute delay to the procedure.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the visual inspection confirmed that the device is bent at the two extremities.The functionality of the guide wire cannot be given anymore.Two parallel wear marks can be seen on the surface of the guide wire, these marks may indicate that an excessive bending load was applied on the device.Furthermore, the dimensional inspection indicated that the guide diameter is in accordance with the specifications.Based on investigation, the root cause was attributed to an user related issue.The failure was probably caused by improper handling of the device, as an excessive bending load may have been applied to the guide wire without it being fully aligned with the nail.It is also possible that the guide wire was not fully aligned with the bone axis when inserted, which may have led to the deformation.As a reminder, the instructions for use clearly state that: "during the procedure, repeatedly check that the connections between the instruments or between implants and instruments required for the precise positioning and fixing are secure." 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 more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that "management of a fracture of the left humerus, placement of the stryker reduction guide.Attempt to insert a rigid stryker nail.The surgical team noticed an unusual and unexpected deformation of the nailing guide, which caused the nail to jam.As a result, the surgeon changed the method and performed an elastic nailing osteosynthesis of the metaizeau type" additionally there was a 45 minute delay to the procedure.

• Brand Name: GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 HUMERUS Ø2,2X800 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: 14461706
• Report Number: 0009610622-2022-00194
• Device Sequence Number: 11888144
• Product Code: LXH
• UDI-Device Identifier: 04546540195975
• UDI-Public: 04546540195975
• 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): 10/10/2022

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 Model Number: 1806-0093S
• Device Catalogue Number: 18060093S
• Device Lot Number: KU147182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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
• Patient Weight: 88 KG