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

Catalog Number 31-301852

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # 31-301852/ arcos 3.5mm hex drive/ lot # zb170703.Item # 110024780/ monoblock inserter handle/ lot # 040960.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -00458, 0001825034 -2021 -00460.

Event Description

It was reported that upon inspection the tips of the instruments were chipped making them unusable.No patient involvement was noted.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.One arcos 3.5mm hex drive (zb170703), one arcos 3.5mm hex drive (z18i0975), and one monoblock inserter handle (040960) was returned and evaluated.Upon visual inspection there was scuffing on the strike plate of the inserter and the threaded tip had fractured.Both tips of the hex drives had fractured and there were wear marks on the shaft of the devices.The hex drivers were submitted for fracture analysis.Fracture surface artifacts suggest the torsional overload failure mode.Xrf analysis found both hex drivers material to be consistent with 440 stainless steel alloy.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not 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; warsaw IN 46582
• MDR Report Key: 11324333
• MDR Text Key: 244332090
• Report Number: 0001825034-2021-00459
• Device Sequence Number: 1
• Product Code: MAY
• UDI-Device Identifier: 0880304484498
• UDI-Public: (01)0880304484498(11)190305(10)Z18I0975
• Combination Product (y/n): N
• PMA/PMN Number: K09075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 31-301852
• Device Lot Number: Z18I0975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1