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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: 31-323220 3.2mmx20mm rnglc+ acet drl bit lot number 66040920.110010270 g7 osseoti multihole 64mm h lot number 7464704.00625006520 bone scr 6.5x20 self-tap lot number j7458216.00625006520 bone scr 6.5x20 self-tap lot number j7477258.00625006530 bone scr 6.5x30 self-tap lot number j7445617.00625006530 bone scr 6.5x30 self-tap lot number j7487165.110024466 g7 dual mobility liner 50mm h lot number 65803034.110031003 longevity dm bearing 28x50mm lot number 65620493.163663 28mm dia cocr mod hd +3mm nk lot number j7273333.11-301334 arcos con sz d hi 70mm lot number 612050.11-300822 arcos 22x150mm spl tpr dist lot number 553240.The product has been received by zimmer biomet.The investigation is currently in process.Once the investigation has been completed, a follow-up report will be submitted.
Event or Problem Description
It was reported that while tightening the cone body screw onto the distal stem, the screwdriver attached to the torque t handle snapped off inside the screw.Had to use combination of suction and magnets to remove the broken bit.Case was completed after extraction.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the tip is fractured.Rings of wear have been scuffed around the shaft.Discoloration spots are present on the grip.The features of the fracture surface visually align with a torsional overload fracture failure identified.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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
There is no update to the prior event description provided.

• 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: 17325514
• Report Number: 0001825034-2023-01562
• Device Sequence Number: 5641927
• Product Code: KWZ
• UDI-Device Identifier: 00880304484498
• UDI-Public: (01)00880304484498(11)180726(10)ZB180501
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2023

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 Model Number: N/A
• Device Catalogue Number: 31-301852
• Device Lot Number: ZB180501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2023
• 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: 06/20/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2018
• 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: Unknown
• 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: PLEASE SEE H10
• Patient Age: 71 YR
• Patient Sex: Male