MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L28MM; SCREW, FIXATION, BONE

Model Number	657322
Medical Device Problem Codes	Positioning Failure (1158); Material Fragmentation (1261)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2020
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: "the surgeon tried to fix the calcaneus mesh plate with 3.5 mm variax2 locking screws during surgery.7 screws from the mesh were not tightened, went loose and a small chip came off the thread of some of them.Replacements were available to complete the medical procedure successfully.".
Event or Problem Description
As reported: "the surgeon tried to fix the calcaneus mesh plate with 3.5 mm variax2 locking screws during surgery.7 screws from the mesh were not tightened, went loose and a small chip came off the thread of some of them.Replacements were available to complete the medical procedure successfully.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the 7 screws were returned but without the plate.The devices were inspected under a microscope.The threads of the locking mechanism below the screw heads show a plastic deformation (to various extents) for all 7 screws which could explain the loss of the angular locking ability.A straight locking of the screws on the plate could however be performed for 6 out of the 7 screws.One of the screws with lot number d13348 has a thread damage too substantial to be able to lock.Based on investigation, the root cause was most probably user related.The failure was caused by inadequate use of the screw during insertion.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 investigation report will be updated.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L28MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10379516
• Report Number: 0008031020-2020-02087
• Device Sequence Number: 16936069
• Product Code: HWC
• UDI-Device Identifier: 07613327086959
• UDI-Public: 07613327086959
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 10/30/2020

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: 657322
• Device Catalogue Number: 657328
• Device Lot Number: D13363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1