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

Model Number 657312S

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/25/2019

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

When inserting the locking screw (657312s) into the plate ((b)(4)), a thin metal piece was generated.It has been removed and no longer remains in the body.

Manufacturer Narrative

The reported event could be confirmed.The device inspection revealed the following: the screw as well as some metal abrasion / swarf was returned.The damage of the screw thread is clearly visible, the metal abrasion has come of the entire middle section of the screw thread.A close up (taken by the microscope) clearly indicates that the screw had been inserted on an angle from the start, as the metal swarf was getting from thin to thick as the screw was inserted further till the final breakage clearly proves that as well.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.Based on investigation, the root cause was attributed to be user related.The failure was caused by an inadequate applied angle during screw insertion.If any further information is provided, the investigation report will be updated.

Event Description

When inserting the locking screw (657312s) into the plate (4020903s), a thin metal piece was generated.It has been removed and no longer remains in the body.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9614115
• MDR Text Key: 193347098
• Report Number: 0008031020-2020-00112
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327086829
• UDI-Public: 07613327086829
• Combination Product (y/n): N
• PMA/PMN Number: K132502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 657312S
• Device Catalogue Number: 657312S
• Device Lot Number: D50232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1