MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM; PLATE, FIXATION, BONE

Model Number	657312S
Medical Device Problem Codes	Positioning Failure (1158); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "during the initial surgery on the clavicle (left), inserted the screw into the plate once and lock it.When the pulled out the screw to replace it with another one, a piece of metal was generated from the screw thread for locking the screw head".No further information is available.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and a thread could indeed be seen.The visual inspection showed the following: a metallic thread can be identified under microscope.The thread most probably resulted in an improper insertion of the screw, which lead to a shearing of some material from the threading of the device.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by the insertion of the screw with an improper angle, which sheared off the thread, resulting in the debris.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 any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "during the initial surgery on the clavicle (left), inserted the screw into the plate once and lock it.When the pulled out the screw to replace it with another one, a piece of metal was generated from the screw thread for locking the screw head".No further information is available.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11553795
• Report Number: 0008031020-2021-00101
• Device Sequence Number: 3830298
• Product Code: HRS
• UDI-Device Identifier: 07613327086829
• UDI-Public: 07613327086829
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132502
• 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,Followup
• Report Date (Section B): 05/19/2021

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 Expiration Date: 09/30/2025
• Device Model Number: 657312S
• Device Catalogue Number: 657312S
• Device Lot Number: G37815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR