MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER, SELF-HOLDING, SHORT SCREWDRIVER, SELF-HOLDING 3.5 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0238
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "one small tooth broken off screwdriver.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Correction - please refer to d9/h3 - device not returned for investigation.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.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 device is returned or any further information is provided, the investigation report will be reassessed.H3 other text : device disposition is unknown.
Event or Problem Description
As reported: "one small tooth broken off screwdriver.".
Additional Manufacturer Narrative
Correction - please refer to d9/h3 - the product was returned for investigation.The reported event could not be confirmed, since the returned device was found to be fully functional and conforming to specifications.The device inspection revealed the following: the received screwdriver showed normal signs of usage evident by presence of scratch marks and normal wear.The inner shaft, outer sleeve, handle and thumbwheel, all were found to be in good condition.The drive section didn't show any remarkable damage or deformation.The movable blade was intact as well.No breakage could be confirmed as alleged in the event.The functional check of the returned screwdriver was done with a sample locking screw.As a result, it was found that the screwdriver was able to hold the screw well and no functional deficit was found in the screwdriver.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, since the device was found to be functional, the real root cause of the alleged issue could not be determined but most likely the issue is user related.If any further information is provided, the investigation report will be reassessed.
Event or Problem Description
As reported: "one small tooth broken off screwdriver.".

• Brand Name: SCREWDRIVER, SELF-HOLDING, SHORT SCREWDRIVER, SELF-HOLDING 3.5 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 15947175
• Report Number: 0009610622-2022-00574
• Device Sequence Number: 6371559
• Product Code: LXH
• UDI-Device Identifier: 04546540520432
• UDI-Public: 04546540520432
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2024

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 Model Number: 1806-0238
• Device Catalogue Number: 18060238
• Device Lot Number: KMW351601
• 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: 11/15/2022
• Supplement Date Received by Manufacturer: 01/19/2023; 02/14/2024
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 02/15/2023; 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2017
• 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