MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FIXATION SCREW T2 FEMUR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-1007
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported that when the femoral nail was locked, a false hole was drilled.The nail was difficult to detach from the targeting device after implantation.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.Known from previous cases it could not be excluded that most likely the user didn't tighten the fixation screw completely (nail adapter has play) or heavy bending forces were applied during drilling (user related).Pre-damage of fixation screw could also not be excluded but should have been noticed during functional check prior to surgery.The ifu and instructions for cleaning, sterilization, inspection and maintenance include that every instrument must be cleaned, sterilized and checked successfully prior to every surgery.Furthermore, the user shall be trained and familiar with the system and operative techniques.The operative technique describes in detail the functional check.However, any device inevitably suffers from long and frequent use.Referring to the very long period since manufacturing [manufactured in 2007] the device has reached the end of its useful service-life and had fulfilled its tasks in former surgeries as intended, until the reported event, without problems reported.Finally, more detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint event.The file will be closed formally in accordance to our procedures.In case the item and / or substantive information will become available in future the file will be reviewed and reopened.H3 other text: device disposition is unknown.
Event or Problem Description
It was reported that when the femoral nail was locked, a false hole was drilled.The nail was difficult to detach from the targeting device after implantation.

• Brand Name: FIXATION SCREW T2 FEMUR
• 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: 12425610
• Report Number: 0009610622-2021-00679
• Device Sequence Number: 4181403
• Product Code: LXH
• UDI-Device Identifier: 07613327095449
• UDI-Public: 07613327095449
• 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
• Report Date (Section B): 12/01/2021

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: 1806-1007
• Device Catalogue Number: 18061007
• Device Lot Number: K830138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2007
• 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