MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, T10 FULL THREAD, 2.7MM/L16MM; SCREW, FIXATION, BONE

Model Number	657016S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.
Event or Problem Description
It was reported: fracture of the distal clavicle.Variax clavicle plate superior 3 lateral holes was used.A screw was inserted on the lateral side, but locking was not possible.It is possible that it was inserted by drilling at an excessive angle.
Event or Problem Description
It was reported: fracture of the distal clavicle.Variax clavicle plate superior 3 lateral holes was used.A screw was inserted on the lateral side, but locking was not possible.It is possible that it was inserted by drilling at an excessive angle.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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 reported event.However, based on the device history review, some possible root causes are, but are not limited to: - the locking part of the screw thread could have been stripped during the usage of the screw, preventing the locking mechanism to function properly.This could have lead to the creation of a slope in the thread preventing the screw to fully engage in the plate, and so, it prevented the locking mechanism to work.- this is a single use device, however it cannot be excluded that the damages to the thread occurred in a previous usage of this device.Note that the ifu clearly required the users to discard the devices after a use.- note that the insertion angle of the locking screw should be a cone with 30° angle.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.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LOCKING SCREW, T10 FULL THREAD, 2.7MM/L16MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10334398
• Report Number: 0008031020-2020-01977
• Device Sequence Number: 825962
• Product Code: HWC
• UDI-Device Identifier: 07613327071283
• UDI-Public: 07613327071283
• 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): 10/19/2020

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: 07/04/2023
• Device Model Number: 657016S
• Device Catalogue Number: 657016S
• Device Lot Number: 1000304766
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1