MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN LH 130 DEG 9MM X 380MM; PROSTHESIS TRAUMA

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
On an unknown date a patient had an initial surgery.On another unknown date the patient came in for a revision due to an implanted nail fracture.
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Device evaluated by mfr: customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Cmp-(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.
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 returned product identified the product has fractured and all the pieces were returned.The set screw is still attached to one of the fractured pieces.Device was submitted for further analysis.Analysis determined the fracture surface showed that the hip fracture nail sample fractured due to fatigue.Fracture surface appeared relatively flat with no evidence of macro artifacts.The fracture surface showed smearing likely due to post fracture damage.Fatigue mode of fracture and suspected fatigue striations observed in the non-smeared areas.Xrf analysis of the hip fracture nail sample showed that it was consistent with ti-6al-4v alloy.Device history record was reviewed and no discrepancies relevant to the reported event were found.The complaint was re-opened due to product return.The results of the original investigation have not changed; 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.

• Brand Name: HFN LH 130 DEG 9MM X 380MM
• Common Device Name: PROSTHESIS 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: 15199681
• Report Number: 0001825034-2022-01828
• Device Sequence Number: 16704196
• Product Code: HSB
• UDI-Device Identifier: 00887868039713
• UDI-Public: (01)00887868039713(17)271006(10)344680
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/12/2023

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: 814609380
• Device Lot Number: 344680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/27/2022
• Supplement Date Received by Manufacturer: 08/24/2022; 10/20/2022; 04/07/2023
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 08/25/2022; 11/09/2022; 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2017
• 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 Sex: Unknown