MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW AXSOS 4.0MM / L36MM; PLATE, FIXATION, BONE

Catalog Number	371536
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device evaluated by mfr: part of device remains implanted; disposition of remainder of device is unknown.
Event or Problem Description
As reported: "the head of the screw was split when trying to put it to the end, it was happening manually, in the same direction as the guide.The screw is blocked during the same procedure, one of the screws did not pass properly through the plate, was changed by another and this did not enter in its totalidade." additionally: "remains a screw without head inside the patient." procedure was completed successfully without adverse consequences.
Event or Problem Description
As reported: "the head of the screw was split when trying to put it to the end, it was happening manually, in the same direction as the guide.The screw is blocked during the same procedure, one of the screws did not pass properly through the plate, was changed by another and this did not enter in its totalidade." additionally: "remains a screw without head inside the patient." procedure was completed successfully without adverse consequences.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided despite multiple attempts.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.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 AXSOS 4.0MM / L36MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8862856
• Report Number: 0008031020-2019-01009
• Device Sequence Number: 1938421
• Product Code: HRS
• UDI-Device Identifier: 07613154864263
• UDI-Public: 07613154864263
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K050512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2019

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 Catalogue Number: 371536
• Device Lot Number: Y12252
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1