MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L18MM; SCREW, FIXATION, BONE

Model Number	657318S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2020
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: "[event details] when the clavicle hook plate was operated, the locking screw did not lock in the locking hole.Plate used: 628535s.Location of defective lock: front side of the plate's most distal hole occurrence status: insert 3 screws after setting the plate ((1) elliptical hole: non-locking, (2) round hole next to the ellipse distal side: rocking, (4) far-most rear circular hole: rocking) a phenomenon that the locking screw does not lock when the locking screw is inserted 18mm into the 4th most distal locking hole set it there and insert the locking screw into the most recent hole (lock without any problem).I tried the following for holes that did not lock again check the drilling direction ¿ no problem (the guide sleeve was within the swing range) confirmation of plate lip and screw head ¿ no interstitial tissue such as soft tissue can be confirmed on the lip.As far as i could see the screw head, it seemed to be no problem.Change the drill direction and insert another locking screw 16 mm again, but it does not lock.Finally, at the discretion of dr., it ends without inserting a screw into the hole." "the plate is currently inside the patient's body [.]." additional information from sales rep: i don't know when it happened, but i think that the lip of the plate has broken.There was nothing wrong with dr's movements during drilling and insertion, and he did the same as in the other holes, so the cause is unknown.For patients, it has been confirmed that there is no problem with immobility by confirming the range of motion after immobilization, and it is considered that there is currently no health hazard or adverse event.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the devices were inspected under a microscope.The threads of the locking mechanism below the screw heads saw a plastic deformation (to various extend) both screws which could explain the loss of the angular locking ability.A straight locking of the screws on the plate could however be performed.Based on investigation, the root cause was most probably user related.The failure was caused by inadequate use of the screw during insertion.Based on available information, no further action is required at this time.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 or Problem Description
As reported: "[event details] when the clavicle hook plate was operated, the locking screw did not lock in the locking hole.Plate used: 628535s location of defective lock: front side of the plate's most distal hole occurrence status: - insert 3 screws after setting the plate ((1) elliptical hole: non-locking, (2) round hole next to the ellipse distal side: rocking, (4) far-most rear circular hole: rocking) - a phenomenon that the locking screw does not lock when the locking screw is inserted 18mm into the 4th most distal locking hole - set it there and insert the locking screw into the most recent hole (lock without any problem) - i tried the following for holes that did not lock again - check the drilling direction ¿ no problem (the guide sleeve was within the swing range) - confirmation of plate lip and screw head ¿ no interstitial tissue such as soft tissue can be confirmed on the lip.As far as i could see the screw head, it seemed to be no problem.- change the drill direction and insert another locking screw 16 mm again, but it does not lock - finally, at the discretion of dr., it ends without inserting a screw into the hole." "the plate is currently inside the patient's body [.]." additional information from sales rep: - i don't know when it happened, but i think that the lip of the plate has broken.- there was nothing wrong with dr's movements during drilling and insertion, and he did the same as in the other holes, so the cause is unknown.- for patients, it has been confirmed that there is no problem with immobility by confirming the range of motion after immobilization, and it is considered that there is currently no health hazard or adverse event.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L18MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10597565
• Report Number: 0008031020-2020-02277
• Device Sequence Number: 373095
• Product Code: HWC
• UDI-Device Identifier: 07613327086904
• UDI-Public: 07613327086904
• 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): 11/16/2020

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 Expiration Date: 07/31/2024
• Device Model Number: 657318S
• Device Catalogue Number: 657318S
• Device Lot Number: D43067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: 09/04/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1