MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW,T8 FULL THREAD, 2.7MM/L18MM; SCREW, FIXATION, BONE

Model Number	656312S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2020
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 screwing in a 2.7 dr screw, it did not block and could be turned.Replacement was available." additional information: "yes, it has been pre-drilled.The bone quality was very poor." surgical delay of 2 minutes not longer.No other consequences reported.
Additional Manufacturer Narrative
Corrections: please refer to sections d4 (catalog number, lot number, gtin number).The reported event could not be confirmed, since the device was returned and is fully functional.The device inspection revealed the following: both screws which were returned are inserted into the plate and can not be taken out.However, one of the two screws (1000346368) is not "blocked", since it can still turn within the plate.The screw is locked but is not blocked.The video provided by the surgeon confirms the event.This is probably due to the deformation of the threads below the head of the screw.The second screw (1000349272 - the device of this complaint) is locked and blocked, so the event reported can not be confirmed for this implant.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: "when screwing in a 2.7 dr screw, it did not block and could be turned.Replacement was available.".Additional information: "yes, it has been pre-drilled.The bone quality was very poor.".Surgical delay of 2 minutes not longer.No other consequences reported.

• Brand Name: LOCKING SCREW,T8 FULL THREAD, 2.7MM/L18MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11016249
• Report Number: 0008031020-2020-02555
• Device Sequence Number: 869703
• Product Code: HWC
• UDI-Device Identifier: 07613327070675
• UDI-Public: 07613327070675
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/05/2021

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: 04/03/2024
• Device Model Number: 656312S
• Device Catalogue Number: 656318S
• Device Lot Number: 1000349272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1