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

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).D10: 31-301858 item name arcos taper disasmbly 70mm lot # zb180502.Multiple mdr reports were filed for this event, please see associated reports 0001825034 - 2023 - 02566.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 Description

It was reported that the disassembly bolt worked as intended during surgery.When the procedure was completed, the disassembly bolt from the proximal body had cross threaded.The proximal body-tip of 3.5 hex driver also broke trying to provide counter torque to release disassembly bolt from proximal body.The patient was no affected in any way.There is no additional information available at the time of this report.

Event Description

There is no update to the prior event description provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the tip of the hex driver to be fractured.The tip was not returned.Rings of wear have been scuffed around the shaft.Discoloration spots are present on the grip.The connector is lightly nicked and scratched.The features of the fracture surface visually align with zrm in which a bending overload fracture failure mode was identified.Complaint confirmed based on the evaluation of the returned product.Review of the device history record(s) 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.

• Brand Name: ARCOS 3.5MM HEX DRIVE
• Type of Device: 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: 18072353
• MDR Text Key: 327377866
• Report Number: 0001825034-2023-02565
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00887868477898
• UDI-Public: (01)00887868477898(11)150901(10)ZB150701
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 31-301852
• Device Lot Number: ZB150701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PLEASE SEE H10.
• Patient Sex: Male