MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AFFIXUS HIP FRACTURE NAIL LAG SCREW 10.5MMX110MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES/TRAUMA

Catalog Number	814510110
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 814501080, hfn a/r screw 80mm; lot#: sp1122280f; item#: 814503000, hfn end cap flush; lot#: td1113 b; item#: 814511180; hfn 130 deg 11mm x 180mm; lot#: 748660.G2: foreign: poland.H3: 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 that the patient underwent an initial hip fracture surgery approximately seven (7) years ago, subsequently, the patient is able to palpate the lag screw through the skin and this is causing the patient discomfort.The surgeon has recommended that the screw be explanted from the patient.A revision surgery has not been scheduled.Multiple attempts have been made to obtain additional information, but no response has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following section was corrected: health effect - impact code, device revision or replacement.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial hip fracture surgery approximately seven (7) years ago, subsequently, the patient is able to palpate the lag screw through the skin and was causing the patient discomfort.The patient underwent a revision surgery on and unknown date and all implants were removed.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive 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: AFFIXUS HIP FRACTURE NAIL LAG SCREW 10.5MMX110MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES/TRAUMA
• 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: 18924090
• Report Number: 0001825034-2024-00746
• Device Sequence Number: 6248097
• Product Code: HSB
• UDI-Device Identifier: 00887868039041
• UDI-Public: (01)00887868039041(17)260426(10)C1132310A
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K100238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2026
• Device Catalogue Number: 814510110
• Device Lot Number: TC1132310A
• 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: 03/04/2024
• Supplement Date Received by Manufacturer: 03/26/2024; 08/27/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/09/2024; 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown