MAUDE Adverse Event Report: STRYKER GMBH FEMORAL NAIL RETROGRADE T2 ALPHA FEMUR RETROGRADE Ø11X380MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23391138S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported by the sales rep that a retrograde t2 alpha femur nail and an unknown screw broke postoperatively.Revision surgery took place on (b)(6) 2024.
Event or Problem Description
It was reported by the sales rep that a retrograde t2 alpha femur nail and an unknown screw broke postoperatively.Revision surgery took place on (b)(6) 2024.
Additional Manufacturer Narrative
The reported event was confirmed by return of a broken retrograde nail.The nail was completely broken in the thinned webs of the round drill hole distally to the oblong drill hole at distal.The webs had started breaking at lateral, continued towards medial and became completely separated in small residual fractures at medial.The appearance of the breakage surfaces identified the nail had broken in fatigue manner ¿ indicated by lines of rest, smooth surfaces, rubbed shiny and missing plastic deformation.The incipient crack had started at the smallest cross section at lateral and had progressed towards medial.Due to breakage no function was given.Manufacturing and inspection records confirmed the item had been released in accordance with specs.Dimensional inspection on the returned item revealed no deficiency in the applicable undamaged areas.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 the case presented a patient (no data given) had been treated with above nail due to an undefined bone breakage on an unknown date.The date of event was quoted being march 25, 2024, and the date of explantation was reported as (b)(6) 2024.X-rays and further information were not provided.The place of breakage, distal to the oblong drill hole at distal, can be named unique because until date all confirmed breakages of a t2alpha retrograde nail were located proximal to the oblong hole at distal.Considering that the distal fragment only presented a short lever it can only be assumed that excessive high load had been applied to the construct.With available information a real cause for breakage could not be determined.With available information a deficiency of the device could not be verified.If more information is provided, we reserve the right to reopen the case and to reassess a root cause.

• Brand Name: FEMORAL NAIL RETROGRADE T2 ALPHA FEMUR RETROGRADE Ø11X380MM
• 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: 19135195
• Report Number: 0009610622-2024-00159
• Device Sequence Number: 4682921
• Product Code: HSB
• UDI-Device Identifier: 07613327293715
• UDI-Public: 07613327293715
• 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 Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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: 23391138S
• Device Lot Number: K15E581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• 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