MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS MODULAR REVISION SYSTEM HEX DRIVER; 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	05/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.D10: cat# 31-301300 lot# zb140401 arcos con sz a std 50mm trl.Cat# 11-300816 lot# 65960765 arcos 16x150mm spl tpr dist.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 during a right hip procedure, the proximal body trial was stuck on the distal stem.While trying to loosen the set screw of the proximal body, the set screw driver broke.A slaphammer was used to remove the trail from the stem.The case took an extra two hours to remove the trial from the stem.A different stem was used to complete the procedure.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual inspection identified that the screw head has been stripped inside of the body and so the body could not be separated from the stem.There are some indentations to the stem attached to the body.The driver had fractured at the tip and there are visible wear lines on the shaft.Additionally, the features of the fracture surface visually align with torsional overload fracture failure mode.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.The complaint is confirmed based on the returned fractured device.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 information is available at the time of this report.
Event or Problem Description
It was reported that during a right hip procedure, the proximal body trial was stuck on the distal stem.While trying to loosen the set screw of the proximal body, the set screw driver broke.The case took an extra two hours to remove the trial from the stem.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: unk stem; unk trial proximal body.The customer has indicated that the product will not be returned to zimmer biomet for investigation as is location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: ARCOS MODULAR REVISION SYSTEM HEX DRIVER
• 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: 19520284
• Report Number: 0001825034-2024-01559
• Device Sequence Number: 12830768
• Product Code: KWA
• UDI-Device Identifier: 00880304484498
• UDI-Public: (01)00880304484498(11)200723(10)ZB6771570
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 10/08/2024
• 2 Devices were Involved in the Event: 1 2

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: ZB6771570
• 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: 05/20/2024
• Supplement Date Received by Manufacturer: 06/20/2024; 10/04/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 07/11/2024; 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Male