MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L70MM; PLATE, FIXATION, BONE

Catalog Number 657370

Device Problem Material Fragmentation (1261)

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

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

During intraoperative exchange of a variax2 screw a thin metal thread occur.Variax elbow plate remained in the patient.

Manufacturer Narrative

The reported event that bone screw variax2 t10, full thread, 3.5mm / l40mm was alleged of 'device damaged' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure may have been caused by inappropriate positioning during screw insertion which resulted in the abrasions on the entire length of the screw thread.The device inspection revealed the following: the returned screw is in bad condition.Firstly, the damages on the t7 drive of the screw head indicate, that high mechanical force had been applied during screw insertion / exchange.It is clearly visible that the entire length of the tread has been damaged.We do suppose that inappropriate positioning during screw insertion (on an angle) has finally caused these damages / abrasions during the screw exchange.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.

Event Description

During intraoperative exchange of a variax2 screw a thin metal thread occur.Variax elbow plate remained in the patient.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L70MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7656792
• MDR Text Key: 113197324
• Report Number: 0008031020-2018-00488
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327087482
• UDI-Public: 07613327087482
• 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: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 657370
• Device Lot Number: L45623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Date Manufacturer Received: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other