MAUDE Adverse Event Report: STRYKER GMBH 1.2X4MM BONE SCREWS,CROSS-PIN,SELF-T; PLATE, FIXATION, BONE

Model Number	58-12004E
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the head of the screw went through the plate without locking to the plate.There was a 5 minute delay to surgery and an alternative screw was used to complete the surgery.
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 shows signs of usage as the threads of the screw are found deformed.The head of the screw is also damaged and deformed.The screw is damaged on a particular side probably due to misalignment and the screw head is deformed most likely due to the over-torqueing while insertion.The device history record could not be reviewed although the affected device was returned but the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause was attributed to a user-related issue.The failure was most likely caused by mishandling/misalignment of the screw while insertion along with the application of higher torque than required.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the head of the screw went through the plate without locking to the plate.There was a 5 minute delay to surgery and an alternative screw was used to complete the surgery.

• Brand Name: 1.2X4MM BONE SCREWS,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: 16131351
• Report Number: 0008031020-2023-00015
• Device Sequence Number: 18023611
• Product Code: HRS
• UDI-Device Identifier: 07613154583126
• UDI-Public: 07613154583126
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K062498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2023

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 Model Number: 58-12004E
• Device Catalogue Number: 58-12004E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 03/29/2023
• 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 Sex: Unknown