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

Model Number	1806-0203
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported:"tip of screwdriver broke while inserting 5.0 screw".
Event or Problem Description
As reported:"tip of screwdriver broke while inserting 5.0 screw".
Additional Manufacturer Narrative
Correction: please refer to h6 clinical code.The reported event could not be since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible as the product was not returned for investigation.A review of the labeling did not indicate any abnormalities.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.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.With available information a root cause could not be determined.In case other essential information becomes available we reserve the right to reopen the case for investigation and to assess a new root cause.

• Brand Name: SCREWDRIVER, SELF-HOLDING, EXTRA SHORT SCREWDRIVER, SELF-HOLDING 3.5 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13057637
• Report Number: 0009610622-2021-00825
• Device Sequence Number: 1609079
• Product Code: LXH
• UDI-Device Identifier: 04546540520418
• UDI-Public: 04546540520418
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2022

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: 1806-0203
• Device Catalogue Number: 18060203
• Device Lot Number: KMW350702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2008
• 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