MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L20MM; SCREW, FIXATION, BONE

Model Number	657320
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded by customer.
Event or Problem Description
According to the surgeon, the customer had locking problems when using the t10 3.5mm variax 2 locking screws in the distal holes of the variax plates, distal humerus (ulnar and radial) and distal radius.The screws have not locked at a stable angle.Bone screws were used to complete the surgery successfully.Surgical delay of 5min.Not longer.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L20MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10334374
• Report Number: 0008031020-2020-01976
• Device Sequence Number: 825960
• Product Code: HWC
• UDI-Device Identifier: 07613327086928
• UDI-Public: 07613327086928
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2020

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: 657320
• Device Catalogue Number: 657320
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1