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

Catalog Number 23510100

Device Problems Break (1069); Fracture (1260)

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

Event Date 12/18/2023

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: "on both screwdriver bit attachments 2351-0110 and 2351-0100, both rear attachments are broken off.".

Event Description

As reported: "on both screwdriver bit attachments 2351-0110 and 2351-0100, both rear attachments are broken off.".

Manufacturer Narrative

The reported event could be confirmed, since the screwdriver is broken as complained.The device inspection revealed the following: two screwdriver bits were returned for investigation.The end piece of the coupling adapter is broken off at both devices, the fragments were not returned.In general are both devices in a good condition, there are just slight wear marks from normal use visible.The microscopic inspection has shown that both fracture faces have the typical view of a brittle overload fracture with a shear lip on one side.The shear lip indicates that the devices were exposed to high lateral forces when they broke.Based on that it can be concluded that a combination of high torsional and lateral forces did lead to a mechanical overload.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material 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 investigation, the root cause was attributed to a user related issue.There was no information provided how or when the screwdrivers broke, based on the performed investigation did a mechanical overload by applying too much torque and lateral stress lead to the breakage of the devices.If more information is provided, the case will be reassessed.

• 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: 18479738
• MDR Text Key: 332755962
• Report Number: 0009610622-2024-00020
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07613327376456
• UDI-Public: 07613327376456
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

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: KP477111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2022
• 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