MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ANKLE LOCKING NAIL 11 X 180MM X 180MM; PROSTHESIS, TRAUMA

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Birth year: (b)(6).Concomitant medical devices: 14-405024 496870 ti-dble lead cort 5.0x24mm scr; 14-405022 434380 ti-dble lead cort 5.0x22mm scr; 14-405044 752180 ti-dble lead cort 5.0x44mm scr; 14-405026 435030 ti-dble lead cort 5.0x26mm scr; 14-405044 873540 ti-dble lead cort 5.0x44mm scr.Foreign country: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient was implanted with an ankle locking nail.Subsequently, the patient was revised approximately two months later due to pain caused by a fractured nail seen on x-ray.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a4; b7.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records and radiographs received.Review of the available records identified the nail was fractured at the dynamic locking hole that occurred during the healing process.The broken nail and locking pins were removed.A new nail was implanted with no complications.Radiographs were provided and reviewed by a health care professional.Review of the available records identified there is a fracture of the nail with angulation apex dorsal at the level of the talus.No screw fractures were noted.There is radiolucency at the distal aspect of the nail within the canceleus.Visual examination of the returned product identified the nail was fractured into 2 pieces, with wear of the anodized coating in some locations of the device.The screws had thread deformations and the nail had contact damage.The device was submitted for further analysis.Analysis determined the fracture is due to fatigue, which then led to bending overload.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ANKLE LOCKING NAIL 11 X 180MM X 180MM
• Common Device Name: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11606729
• Report Number: 0001825034-2021-00966
• Device Sequence Number: 19656118
• Product Code: HSB
• UDI-Device Identifier: 00887868093609
• UDI-Public: (01)00887868093609(17)290520(10)249840
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2021

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: 14-440218
• Device Lot Number: 249840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 05/28/2021; 08/06/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 06/15/2021; 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 87