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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed a follow-up mdr will be submitted report source: (b)(6).

Event Description

It was reported that during inspection at the warehouse, the tip of the instrument was found to be fractured.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information to the reported even 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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.A review of the device history records identified deviations or anomalies during manufacturing, however, the deviations or anomalies would not have attributed to the event.Root cause was unable to 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d9; g3; h2; h3.An arcos 3.5mm hex drive, part # 31-301852 from lot zb160507, was returned and evaluated against the complaint.Visual inspection found the tip to be fractured.Wear rings are present around the shaft.Discoloration and scuffing was observed on the grip and connector.The features of the fracture surface visually align with in which a torsional overload fracture failure mode was identified.The additional information does not change the outcome of the previous investigation.

Event Description

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

• 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
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12216635
• MDR Text Key: 263101195
• Report Number: 0001825034-2021-02135
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2022

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 Catalogue Number: 31-301852
• Device Lot Number: ZB160507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 10/14/2021; 03/02/2022
• Supplement Dates FDA Received: 10/21/2021; 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1