MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 3.5MM HEX DRIVE; INSTRUMENT, HIP

Catalog Number	31-301852
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the procedure the screwdriver broke inside the cone body.There was no harm or health consequences to the patient.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: cat #: 31-301303 / arcos con sz c std 60mm trl / lot #: 481100.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned product identified the hex driver had fractured at the tip with were marks visible on the shaft of the device.The returned trial has scuffing on the outside of the device with no damage to the threads or taper.The returned stem has scuffing on the taper in two locations.Additionally, the fracture surface visually align with zrm in which a torsional overload fracture failure mode was identified.Complaint confirmed based on evaluation of the returned products.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot be determined.However it is noted that per the surgical technique "thread the locking screw into the top of the proximal body using the 3.5 mm hex driver and the t-handle in torque limiting position until a ¿click¿ is felt and heard".If the driver is torqued past the point of clicking torsional fracture may occur.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 additional event information to report at this time.

• Brand Name: ARCOS 3.5MM HEX DRIVE
• Common Device Name: INSTRUMENT, HIP
• 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: 17739374
• Report Number: 0001825034-2023-02171
• Device Sequence Number: 20500459
• Product Code: KWA
• UDI-Device Identifier: 00887868477898
• UDI-Public: (01)00887868477898(11)170512(10)ZB170201
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 31-301852
• Device Lot Number: ZB170201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• 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: 08/23/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Patient Sex: Unknown