MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L32MM; SCREW, FIXATION, BONE

Model Number	657432
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	02/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.Few x-rays were provided.However, based on these information, no root cause could be determined.A review of the device history was not possible because the lot number 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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "original case was for a bunion deformity, where a lapidus procedure was performed (b)(6) 2019.Dissection, joint preparation, and fixation during the case went flawless.No concerns on day of the case.The patient presented 4-6 weeks out with possible non union.Upon the next xrays taken, a non union was shown, and a few screws used through the plate were broken from the movements and instability caused by the non union at the fusion site." date of explant reported: (b)(6) 2020.

• Brand Name: BONE SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L32MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10657367
• Report Number: 0008031020-2020-02302
• Device Sequence Number: 19619463
• Product Code: HWC
• UDI-Device Identifier: 07613327074048
• UDI-Public: 07613327074048
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 657432
• Device Catalogue Number: 657432
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention