MAUDE Adverse Event Report: STRYKER GMBH FEMORAL NAIL RETROGRADE T2 ALPHA FEMUR RETROGRADE Ø13X380MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23391338S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	03/13/2024
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.H3 other text : the device was discarded.
Event or Problem Description
It was reported a patient underwent a revision due to a broken nail and nonunion.The patient was revised to another alpha retrograde nail.
Additional Manufacturer Narrative
The reported event could be confirmed, based on x-rays provided, only, a broken nail could be verified.A physical device inspection was not possible since the affected device was not returned and thus, evaluation limited to details available.Based on x-ray images provided the reported nail breakage could be verified.The nail broke proximally above the oblong hole at the distal end.According to event details given within product inquiry the item was revised by another alpha retrograde nail (catalogue number 2339-1438s) on (b)(6) 2024 after primary surgery took place on (b)(6) 2022, which is a clear hint that the fracture was not healed at all after an implantation duration of approximately 19 months.Furthermore, a non-union, also confirmed by event description ¿revision reason: non union, broken hw¿ was present.Finally, it is unknown which post-operative weight-bearing behavior instructions were given by the surgeon and if the patient was compliant to this.One requirement for successful nail treatment is a timely bone healing in order to relieve the implant(s) over the progressing time of implantation.Potential adverse effects are clearly pointed out in the labelling.Nevertheless, based on the information given an exact root cause of the reported event could not be determined and a thorough technical statement was impossible, but it could not be excluded that it is rather related to patient conditions (non-union) and thus, classified as patient-patient factors issue.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
It was reported a patient underwent a revision due to a broken nail and nonunion.The patient was revised to another alpha retrograde nail.

• Brand Name: FEMORAL NAIL RETROGRADE T2 ALPHA FEMUR RETROGRADE Ø13X380MM
• 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: 19067908
• Report Number: 0009610622-2024-00145
• Device Sequence Number: 6016999
• Product Code: HSB
• UDI-Device Identifier: 07613327293531
• UDI-Public: 07613327293531
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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: 23391338S
• Device Lot Number: K01CB4D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2021
• 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 Age: 43 YR
• Patient Sex: Male