MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX FULL THREAD 2.7MM / L12MM; PLATE, FIXATION, BONE

Model Number	614512
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2020
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
It was reported that the 2.7 and 3.5 t10 locking screws did not lock into the plate in the most medial screw hole and two lateral screw holes in a superior lateral plate.New screws were used.

• Brand Name: LOCKING SCREW VARIAX FULL THREAD 2.7MM / L12MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9684759
• Report Number: 0008031020-2020-00318
• Device Sequence Number: 3414044
• Product Code: HRS
• UDI-Device Identifier: 07613154969487
• UDI-Public: 07613154969487
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K101056
• 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): 02/07/2020

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: 614512
• Device Catalogue Number: 614512
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1