MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L14MM; PLATE, FIXATION, BONE

Catalog Number	657314S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported: "during the installation of a locked screw on a plate, a steel wire came loose.The wire pricked the surgeon's finger.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported: "during the installation of a locked screw on a plate, a steel wire came loose.The wire pricked the surgeon's finger.".
Additional Manufacturer Narrative
Please note correction to section b1.The reported event could be confirmed, since a piece of the thread is peeled off.The device inspection revealed the following: the locking screw and a bag with the reported metal chip was returned for evaluation.The microscopic evaluation of the screw shows that the thread flank of the locking thread is completely peeled off.The anodized layer is not present anymore, which indicates that the damage occurred post-manufacturing.The thread at the screw shaft is in a good condition, there are no damages visible.The visual inspection of the t10 recess shows that there are deformations in clockwise direction visible.These deformations are a sign that high forces were applied onto the screw during the insertion.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.No product related issue could be detected.Most likely did an excessive contact between the locking thread of the screw and the plate (e.G by placing the screw out of center, an excessive insertion angle or a damage at the plate interface) lead to the peel off of the thread flank.However, to define the exact root cause the affected plate must also be available for evaluation.If any additional information is provided, the investigation will be reassessed.
Additional Manufacturer Narrative
Please note correction/update to sections b1 and h1.New information in b5.
Event or Problem Description
The customer reported: "during the installation of a locked screw on a plate, a steel wire came loose.The wire pricked the surgeon's finger.".01/16/2024 - additional information.The screw thread split when it was fitted to an osteosynthesis plate.The incident therefore occurred during the operation, causing no malfunction for either the operation or the patient.The problem was that the surgeon was pricked by the metal wire detaching from the screw thread.

• Brand Name: LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L14MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18424445
• Report Number: 0008031020-2024-00001
• Device Sequence Number: 7697655
• Product Code: HRS
• UDI-Device Identifier: 07613327086850
• UDI-Public: 07613327086850
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 657314S
• Device Lot Number: AC9929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 03/05/2024; 05/17/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 04/01/2024; 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown