MAUDE Adverse Event Report: STRYKER GMBH FEMORAL NAIL, A/R T2 FEMUR Ø10X360 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18251036S
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As per the legal department'' bghm (berufsgenossenschaft holz und metall) insurance have reported that there is an increase in lead, chromium, cobalt, zinc and cadmium has been detected in their insured¿s blood and urine.An allegation has been made by the insured patient¿s treating physician that this complaint may be due to the t2 femoral nail implanted in the patient in 2007.".
Event or Problem Description
As per the legal department'' bghm (berufsgenossenschaft holz und metall) insurance have reported that there is an increase in lead, chromium, cobalt, zinc and cadmium has been detected in their insured¿s blood and urine.An allegation has been made by the insured patient¿s treating physician that this complaint may be due to the t2 femoral nail implanted in the patient in 2007.".
Additional Manufacturer Narrative
Please note the correction to d4 lot#.The reported event could not be confirmed during the investigation the reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.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.As requested, the chemical composition (mass percentage) per astm f136 of the implant's material is given below: carbon less than 0.08 aluminium 5.5 ¿ 6.5 vanadium 3.5 ¿ 4.5 iron less than 0.25 oxygen less than 0.13 nitrogen less than 0.05 hydrogen less than 0.012 titanium: balance 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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: FEMORAL NAIL, A/R T2 FEMUR Ø10X360 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21587628
• Report Number: 0008031020-2025-00402
• Device Sequence Number: 9468013
• Product Code: HSB
• UDI-Device Identifier: 04546540199515
• UDI-Public: 04546540199515
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K010801
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2008
• Device Catalogue Number: 18251036S
• Device Lot Number: K887190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2004
• 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