MAUDE Adverse Event Report: STRYKER GMBH SPEEDGUIDE FOR 3.5MM T10 (L=30MM); PLATE, FIXATION, BONE

Catalog Number	703886
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "variax speed drill, which is not used often in surgery, get damaged.Probably just due to sterilizations.The color rings loosen from the drill sleeve.".
Event or Problem Description
As reported: "variax speed drill, which is not used often in surgery, get damaged.Probably just due to sterilizations.The color rings loosen from the drill sleeve.".
Additional Manufacturer Narrative
Please note corrections to section d9/h3.The reported event could not be confirmed, since the device was not returned and no additional information was available.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Additional Manufacturer Narrative
Please note corrections to sections d4 lot#, d9/h3, the device was returned and h6 (method, results and conclusion codes).The reported event could be confirmed, since the device was returned and matches the alleged failure.The return device was visually inspected we can see discoloration and one of the orange color-coding markings has indeed come off, wear on the device is visible from the fading of the identification marking on the device.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.The device was released in march 2018 and has been fulfilling its task since, which led to its normal wear.The lifetime of the device is not specified, but as stated in the cleaning and sterilization guide stryker trauma & extremities typically does not specify the maximum number of uses appropriate for re-usable medical devices.The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "variax speed drill, which is not used often in surgery, get damaged.Probably just due to sterilizations.The color rings loosen from the drill sleeve.".

• Brand Name: SPEEDGUIDE FOR 3.5MM T10 (L=30MM)
• 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: 18029284
• Report Number: 0008031020-2023-00373
• Device Sequence Number: 6924557
• Product Code: HRS
• UDI-Device Identifier: 07613327069969
• UDI-Public: 07613327069969
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/11/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 703886
• Device Lot Number: 100428923
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 11/28/2023; 03/18/2024
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 12/19/2023; 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown