MAUDE Adverse Event Report: STRYKER GMBH HUMERAL NAIL T2 HUMERUS Ø7X240 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18300724S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Impaired Healing (2378); Implant Pain (4561)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
As reported: patient had a shoulder rod (nail) implanted in 2023.According to x-ray on (b)(6) 2024 slowly consolidating fracture of the low 3 of the right humerus with secondary displacement of the fragment in the mos state.Fracture of a metal structure.The reason for going to the hospital was pain in the shoulder joint.The pain appeared in february 2024 and gradually increased".Revision operation is planned on (b)(6) 2024.
Additional Manufacturer Narrative
The reported event could be confirmed, since x-rays were provided.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.This event and associated records were forwarded to medical affairs, resulting in the following review: evaluating the x-ray from on (b)(6) 2023, there seems to be a long extending fracture from midshaft until very distal in the humerus.There is a cerclage and the screws in the distal part of the are only just in the distal part of the fracture.Looking at the x-ray from on (b)(6) 2024 (18 months later) there is clear evidence of a non-union especially of the distal part of the fracture.Since we do not know the follow up in the hospital, we can only conclude that 18 months after the initial surgery, this may be the first evidence of this non-union.The fracture and stability of the construct, especially distally, may have contributed to the non-union, it is imaginable there was too much movement in the fracture site, preventing healing and bone consolidation.In the end the failure to unite led to failure of the implant.Based on the provided information, the root cause of the reported event is multi-factorial: the location of the fracture and the technical aspects of the surgical procedure may have contributed to the event.Furthermore, patient activity levels post-op, co-morbidities may also have contributed to an inadequate load distribution, and therefore the breakage of the implant.Based on investigation, the root cause was attributed to a combination of user and patient condition related issue.The implant breakage occurred as a direct result of the bone non-union, after 18 months of implantation.The choice of the construct and technical aspects of the procedure may also have contributed to the non-union, and therefore failure of the implant.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: patient had a shoulder rod (nail) implanted in 2023.According to x-ray on (b)(6) 2024 slowly consolidating fracture of the low 3 of the right humerus with secondary displacement of the fragment in the mos state.Fracture of a metal structure.The reason for going to the hospital was pain in the shoulder joint.The pain appeared on (b)(6) 2024 and gradually increased".Revision operation is planned on (b)(6) 2024.

• Brand Name: HUMERAL NAIL T2 HUMERUS Ø7X240 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: 20073000
• Report Number: 0009610622-2024-00814
• Device Sequence Number: 19601799
• Product Code: HSB
• UDI-Device Identifier: 04546540201300
• UDI-Public: (01)04546540201300(11)220128(17)261231(10)K0BD997
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K032523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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: Lay User/Patient
• Device Catalogue Number: 18300724S
• Device Lot Number: K0BD997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2022
• 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: Required Intervention
• Patient Sex: Unknown