MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BIT, SHORT IMN INSTRUMENTS 3.5MM

Catalog Number 23510100

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2023

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported: "when removing the als, the screws were hard and the screw heads were worn, so the screws were removed using the self-retaining screwdriver sleeves.The screw and self-retaining screwdriver sleeve are no longer detached.During same surgery, two screwdriver bits were damaged but it is not known under what circumstances they were damaged.".

Manufacturer Narrative

The reported event could be confirmed, since the device was returned, and matches the alleged failure.The received screwdriver bit, short was visually inspected, and we can see that the across corner region of the hex is damaged it is deformed with a material line to the right side from the across line which indicates excessive force application while the screw extraction.This is visible in the locking screw head where we can see misalignment with the head and application of excessive force.It was also seen that left-handed helix threads are also flattened which is feasible from holding it with high force.Further, the dimensional analysis was conducted and the device was within the specification.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.Based on the above investigation the root cause can be attributed to user-related that the deformation of the hex was caused by the application of excessive force.If any additional information is provided, the investigation will be reassessed.

Event Description

As reported: "when removing the als, the screws were hard and the screw heads were worn, so the screws were removed using the self-retaining screwdriver sleeves.The screw and self-retaining screwdriver sleeve are no longer detached.During same surgery, two screwdriver bits were damaged but it is not known under what circumstances they were damaged.".

• Brand Name: SCREWDRIVER BIT, SHORT IMN INSTRUMENTS 3.5MM
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18419804
• MDR Text Key: 331622348
• Report Number: 0009610622-2023-00465
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 23510100
• Device Lot Number: KP490989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Male