MAUDE Adverse Event Report: STRYKER GMBH 1.7X7MM BONE SCREW,CROSS-PIN,SELF-T; PLATE, FIXATION, BONE

Catalog Number	58-17007E
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the surgeon put a variax 2 1.7 cortex screw through a variax hand plate, and saw on the x-ray that the screw looked too long.After removing the screw, it was noticed that it had uncoiled itself and therefore was too long.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received screw was in used condition.The threads of the screw were chipped of in the thread like form.This generally happens when the screw is screwed without proper alignment with the plate and is in direct contact with the plate edge leading to the chip-off of the threads in such manner.The damaged & deformation of the threads on the screw surface also indicates the same.The device history record could not be reviewed because the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause was most likely attributed to a user related issue.The failure was caused by mishandling of the device during usage.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "the surgeon put a variax 2 1.7 cortex screw through a variax hand plate, and saw on the x-ray that the screw looked too long.After removing the screw, it was noticed that it had uncoiled itself and therefore was too long.".

• Brand Name: 1.7X7MM BONE SCREW,CROSS-PIN,SELF-T
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17578667
• Report Number: 0008031020-2023-00309
• Device Sequence Number: 8267777
• Product Code: HRS
• UDI-Device Identifier: 07613154583454
• UDI-Public: 07613154583454
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K062498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2023

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: 58-17007E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male