MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW,T8 FULL THREAD, 2.7MM/L22MM; SCREW, FIXATION, BONE

Model Number	656418
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	06/10/2020
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
The "variax 2 locking screws t10 2.7" did not lock into the plate.New screws were used to complete the surgery successfully.Surgical delay of 15min.Not longer.
Event or Problem Description
The "variax 2 locking screws t10 2.7" did not lock into the plate.New screws were used to complete the surgery successfully.Surgical delay of 15min.Not longer.
Additional Manufacturer Narrative
Correction: refer to d9/h3 device availability.The reported event that bone screw, t8 full thread, 2.7mm/l18mm was alleged of 'implant - insertion impaired' 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 complaint event.However, based on the complaint 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.The ifu clearly requires the users to discard the devices after a use.- 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 was not possible because the lot number was not communicated.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.H3 other text : device disposition is unknown.
Event or Problem Description
The "variax 2 locking screws t10 2.7" did not lock into the plate.New screws were used to complete the surgery successfully.Surgical delay of 15min.Not longer.
Additional Manufacturer Narrative
Correction: refer to section d catalog #, lot # & gtin.The reported event could be confirmed.The inspection of the returned device revealed a broken/deformed thread winding at the thread outlet, causing the screw to not lock into the plate hole.A non-conformity report (nc) was already initiated based on previous complaints reporting the same event.The nc investigation is not finished yet.A review of the device history for the reported lot did not indicate any abnormalities; the screw was manufactured within specifications.A review of the risk management file showed that the reported event is adequately addressed.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.

• Brand Name: LOCKING SCREW,T8 FULL THREAD, 2.7MM/L22MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10277943
• Report Number: 0008031020-2020-01904
• Device Sequence Number: 16775874
• Product Code: HWC
• UDI-Device Identifier: 07613327068955
• UDI-Public: 07613327068955
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2020

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 Model Number: 656418
• Device Catalogue Number: 656322
• Device Lot Number: 1000337801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 07/23/2020; 11/19/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 08/19/2020; 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1