MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN RH 130 DEG 11MM X 380MM; TRAUM IMPLANT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: uk.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient had an initial surgery approximately 2 years ago, she has since had a right broken affixus hip fracture nail which had to be removed and the fracture fixed with a synthes trochanteric hook plate.The original fracture was a sub trochanteric fracture extending distally towards the mid shaft.A cable can be seen on the x-ray at the time of removing the nail showing some callous formation around the mid to proximal section of bone and looks to have healed.The nail had broken at the circle section where the lag screw goes through the nail and into the femoral neck and acetabula head.The femur has fractured from the lateral side approximately 8cm below the greater trochanter and extended medially towards the lesser trochanter and inferior femoral neck.There was no discernable reason as to why the nail had broken.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : will not be returned.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Proposed component code: mechanical (g04) - im nail reported event was unable to be confirmed as the radiographs that were provided identified that through three views of the right hip demonstrate an intramedullary rod and gamma nail fixation for a sub trochanteric hip fracture.Fractured intramedullary rod at the gamma nail.Proximal cerclage wire is still intact.Oblique, now displaced fracture involving the sub trochanteric region with bony callus formation.Additional oblique fracture involving the proximal femoral diaphysis.No dislocation.Osteopenia noted.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed as visual examination of the provided pictures identified the nail has fractured through the lag screw hole.The distal fragment of the fractured nail has scratches present on the outside of the proximal end, which are likely a result of instrumentation used for explantation.The mating surface of the nail to the lag screw and the lag screw itself exhibit markings along the shaft which are consistent with implantation / use / explantation through the nail.Biological debris is present throughout.Part number confirmed; what is visible of the lot number is confirmed.It remains that a root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: HFN RH 130 DEG 11MM X 380MM
• Common Device Name: TRAUM IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14743667
• Report Number: 0001825034-2022-01417
• Device Sequence Number: 5175220
• Product Code: HSB
• UDI-Device Identifier: 00887868039171
• UDI-Public: (01)00887868039171(17)310517(10)797590
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K100238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/24/2023

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 Model Number: N/A
• Device Catalogue Number: 814511380
• Device Lot Number: 797590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 07/18/2022; 08/29/2022; 02/28/2023
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 08/10/2022; 09/01/2022; 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Female