MAUDE Adverse Event Report: STRYKER GMBH 2.5MM NON-THREADED KWIRE; SCREW, FIXATION, BONE

Model Number	KN1115
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the mini screw kwire (kn1115) broke while inserting the screw.The wire was seen in x-ray floating in patient¿s soft tissue.No additional information is available.
Event or Problem Description
It was reported that the mini screw kwire ((b)(6)) broke while inserting the screw.The wire was seen in x-ray floating in patient¿s soft tissue.No additional information is available.
Additional Manufacturer Narrative
The reported event could be confirmed, since the kwire is broken as complained.The device inspection revealed the following: the visual inspection has shown that kwire is broken apart about 11mm above the tip, the fragment was not returned for evaluation.The kwire is deformed above the fracture face and there is a strong notch visible in the area of deformation.This notch was caused by the drill bit, which did cut into the wire in this area.The fracture face has the typical view of a ductile overload fracture, where high force did first lead to permanent distortion and finally the breakage of the device.The relevant dimension was verified during the investigation and no deviation from the specification could be detected.A review of the device history was not possible because the lot number is not marked on the device and was not communicated.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 received kwire was after the insertion deformed, which caused an excessive contact between the drill bit and the kwire, this did finally lead to a mechanical overload and the breakage of the kwire.If more information is provided, the case will be reassessed.

• Brand Name: 2.5MM NON-THREADED KWIRE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13634120
• Report Number: 0008031020-2022-00074
• Device Sequence Number: 16697888
• Product Code: HWC
• UDI-Device Identifier: 07613327363258
• UDI-Public: 07613327363258
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K120493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2022

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: KN1115
• Device Catalogue Number: KN1115
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 36 YR
• Patient Sex: Female