MAUDE Adverse Event Report: STRYKER GMBH LAG SCREW ADAPTER OMEGA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	704009
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "the lag screw adapter broke off.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.Based on investigation, the root cause was attributed to be user related.The failure was caused by the normal wear of the device.The device was released in december 2007, and has been fulfilling its task since, which lead 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 reusable 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.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.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "the lag screw adapter broke off.".

• Brand Name: LAG SCREW ADAPTER OMEGA
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10467332
• Report Number: 0008031020-2020-02194
• Device Sequence Number: 3092028
• Product Code: LXH
• UDI-Device Identifier: 07613153054511
• UDI-Public: 07613153054511
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 11/23/2020

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: 704009
• Device Catalogue Number: 704009
• Device Lot Number: N29380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1