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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 31-301301 arcos con sz a std 60mm trl 061896; 11-300821 arcos 21x150mm spl tpr dist 743970.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the surgeon was tightening the cone body onto the stem.While doing this, the screwdriver broke off into the body.The surgeon could not remove the screwdriver from the body, and another implant and screwdriver needed to be used.No broken pieces were left inside patient.Attempts have been made and no further information has been provided.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Cmp-(b)(4).Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined.An arcos 3.5mm hex drive, part 31-301852 from lot zb121001, was returned and evaluated against the complaint.Visual inspection confirmed the hex tip to be fractured from the driver.The tip remains lodged inside the cone body, however the location prevents the tip from being visible.Wear rings are present around the distal end of the shaft near the fracture.Device has a potential field age of approximately 8 years.The returned device was sent to sem for further analysis.The driver tip fractured angularly to the long axis as detailed.Fracture surface artifacts suggest a torsional overload fracture.Xrf analysis found the hex driver material to be consistent with 430/440 stainless steel alloy.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.

• Brand Name: ARCOS 3.5MM HEX DRIVE
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11223994
• MDR Text Key: 228490002
• Report Number: 0001825034-2021-00142
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

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: ZB121001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 06/16/2021
• Supplement Dates FDA Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1