MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L16MM; PLATE, FIXATION, BONE

Model Number 657316S

Device Problem Material Fragmentation (1261)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.

Event Description

As reported: "when i inserted the screw after drilling as usual, a thin thread-shaped metal piece came out from the screw twice.I pulled it out, and when i looked at the screw, the thread was peeled off.I replaced it with another screw and could insert it safely.The angle of the drill was not bad.After that another screw entered as usual.".

Manufacturer Narrative

The reported event not be confirmed, since the device was not returned.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on complaint history review, some potential root causes are, but are not limited to: - an insertion angle of the locking screw superior to 30°.Indeed, any excesses in the angulation might lead to the non function of the locking mechanism and even the damage of the thread of the screw.- the insertion of the locking screw too close to the plate sides, causing metal on metal abrasion, resulting in the reported screw metal threads.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.

Event Description

As reported: "when i inserted the screw after drilling as usual, a thin thread-shaped metal piece came out from the screw twice.I pulled it out, and when i looked at the screw, the thread was peeled off.I replaced it with another screw and could insert it safely.The angle of the drill was not bad.After that another screw entered as usual.".

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L16MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10467339
• MDR Text Key: 206794738
• Report Number: 0008031020-2020-02196
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327086881
• UDI-Public: 07613327086881
• Combination Product (y/n): N
• PMA/PMN Number: K132502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

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
• Device Operator: Health Professional
• Device Model Number: 657316S
• Device Catalogue Number: 657316S
• Device Lot Number: D57310
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 10/08/2020
• Supplement Dates FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 55