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

Model Number	657316S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2020
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
As reported, when the locking screw 16mm was inserted into the distal part of the variax distal fibra plate, idling occurred before the final fastening.Once the screw was removed, metal such as wire was wound around the thread of the screw.When the same screw was newly inserted, the locking was loose.The operation was terminated because the other screws were securely locked.Doctor's opinion: the metal wrapped around the screw is a scraped plate.This is why the plate and screw could not be locked, and the new screw was loosened.It is dangerous because there is a possibility of leaving metal scraped inside the body.
Event or Problem Description
As reported, when the locking screw 16mm was inserted into the distal part of the variax distal fibra plate, idling occurred before the final fastening.Once the screw was removed, metal such as wire was wound around the thread of the screw.When the same screw was newly inserted, the locking was loose.The operation was terminated because the other screws were securely locked.Doctor's opinion: the metal wrapped around the screw is a scraped plate.This is why the plate and screw could not be locked, and the new screw was loosened.It is dangerous because there is a possibility of leaving metal scraped inside the body.
Additional Manufacturer Narrative
The reported event that locking screw variax2 t10, full thread, 3.5mm / l16mm was alleged of 'implant - insertion impaired' could not be confirmed.Due to the current covid-19 pandemic, it was not possible to receive the product for evaluation.The investigation will be reassessed as soon as the product is received.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 VARIAX2 T10, FULL THREAD, 3.5MM / L16MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10029081
• Report Number: 0008031020-2020-01429
• Device Sequence Number: 10932282
• Product Code: HRS
• UDI-Device Identifier: 07613327086881
• UDI-Public: 07613327086881
• Combination Product (Y/N): N
• 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): 07/01/2020

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: 01/31/2024
• Device Model Number: 657316S
• Device Catalogue Number: 657316S
• Device Lot Number: D14115
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/10/2020
• Supplement Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR