MAUDE Adverse Event Report: STRYKER GMBH FEMORAL NAIL, A/R T2 FEMUR Ø11X380 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1825-1138S
Medical Device Problem Codes	Material Fragmentation (1261); Difficult to Remove (1528)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Foreign Body In Patient (2687)
Date of Event	03/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.  if additional information becomes available, it will be provided in a supplemental report.Device remains implanted in the patient.
Event or Problem Description
It was reported: "when trying to knock out a t2 femur nail, the knockout thread in the nail broke off.Removal of the nail was no longer possible.The customer is currently looking for alternative ways to remove the nail in a next step.".
Event or Problem Description
It was reported: "when trying to knock out a t2 femur nail, the knockout thread in the nail broke off.Removal of the nail was no longer possible.The customer is currently looking for alternative ways to remove the nail in a next step.".
Additional Manufacturer Narrative
Correction: please refer to h6 / clinical signs code the reported event could not be confirmed, since the device was not returned and from the available radiographs.A device inspection was not possible since the affected device was not returned and no other evidence were provided for investigation.From the available radiographs, a formal medical opinion was sought: "with the available information, there is no way to determine the reason for the breakage of the instrument.[original statements] 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.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Additional Manufacturer Narrative
Correction: please refer to d3 manufacturer entity.
Event or Problem Description
It was reported: "when trying to knock out a t2 femur nail, the knockout thread in the nail broke off.Removal of the nail was no longer possible.The customer is currently looking for alternative ways to remove the nail in a next step.".

• Brand Name: FEMORAL NAIL, A/R T2 FEMUR Ø11X380 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 16713976
• Report Number: 0009610622-2023-00110
• Device Sequence Number: 1614549
• Product Code: HSB
• UDI-Device Identifier: 04546540199652
• UDI-Public: 04546540199652
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 1825-1138S
• Device Catalogue Number: 18251138S
• Device Lot Number: K039FCA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 05/18/2023; 06/14/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 06/07/2023; 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown