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	04/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
On thursday, april 9, an antegrade t2 femur intramedullary nail was performed on a (b)(6) boy.(condition after fixator system).Both proximal locking holes failed; they passed the nail ventrally.The surgeon pulled the nail out a bit and again both locking holes went past the nail ventrally despite the repeated tightening of all screws.The operation was successfully completed with two proximal freehand bores.Surgical delay of 90 minutes not longer.No other consequences reported.
Event or Problem Description
On (b)(6), an antegrade t2 femur intramedullary nail was performed on a 17-year-old boy.(condition after fixator system).Both proximal locking holes failed; they passed the nail ventrally.The surgeon pulled the nail out a bit and again both locking holes went past the nail ventrally despite the repeated tightening of all screws.The operation was successfully completed with two proximal freehand bores.Surgical delay of 90 minutes not longer.No other consequences reported.
Additional Manufacturer Narrative
The reported event could not be confirmed, since during functional check the reported event could not be reproduced.The device inspection revealed the following: a detailed visual inspection revealed that the first screw winding is slightly damaged.A function test with the parts returned [targeting arm, nail handle, fixation screw] and a sample nail could be carried out without any deviation.Although verified damage at the fixation screw, the returned parts could be assembled as intended but it could not be excluded that the reported event occurred due to damage found at the windings.As nothing was reported during functional check prior to surgery, which is required per ifu, the case is obviously linked to a suboptimal intra-operative procedure.In case of intended use such damage would not have occurred.However, each instrument will inevitably suffer from long and frequent use.Referring to the very long period since manufacturing (manufactured in 2012) 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.Due to damage found this item should not be used any longer.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.

• 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
• MDR Report Key: 10870173
• Report Number: 0009610622-2020-00715
• Device Sequence Number: 2601790
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2021

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: K767252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR