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

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).D10: 11-300917 arcos 17x190mm spl tpr dist 66269420; 11-301351 arcos con sz a hi 80mm 600820.G2: foreign: new zealand.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported during a revision of a competitor product due to a fracture, arcos products were used when connecting the proximal body to the distal stem, the torque driver was not switched on.Therefore, when the surgeon added extra power, the screwdriver head broke off inside the implant.The arcos products completed the case.No known impact or consequence to the patient.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected.Visual examination of the provided pictures identified the end of the hex driver is broken.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.The root cause of the reported issue is attributed to a failure to follow instructions as the hex driver was used without the torque limiting function.Per the arcos surgical technique, "to lock the distal and proximal body implants, thread the locking screw into the top of the cone proximal body using the 3.5 mm hex driver and t-handle in the torque limiting position until a ¿click¿ is felt and heard".Complaint confirmed based on the evaluation of the provided images.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional event information to report at this time.

• Brand Name: ARCOS 3.5MM HEX DRIVE
• Type of Device: HIPS, INSTRUMENTS
• 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: 18897379
• MDR Text Key: 337589050
• Report Number: 0001825034-2024-00713
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 0088030448498
• UDI-Public: (01)0088030448498(11)220310(10)ZB7158714
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

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: ZB7158714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• 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: SEE H10 NARRATIVE