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 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4) 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.Concomitant medical products: part: 31-301311, arcos con sz a hi 60mm trl, lot: unk, part: 11-301919, arcos 19x250mm intlkng dist, lot: unk.Report source: (b)(6).

Event Description

It was reported that the 3.5mm hex screwdriver broke off inside the cone proximal body trial whilst trying to remove it from the definitive sts stem.As the trial was now stuck to the definitive stem the whole construct had to be removed from the patient.Removal and reimplantation caused a 60 minute delay in surgery.Attempts have been made and no further information has been provided.

Event Description

Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10 complaint sample was evaluated and the reported event was confirmed.An arcos 3.5mm hex drive, part # 31-301852 from lot z18l2492, was returned and evaluated against the complaint.Visual inspection confirmed the tip of the hex driver to be fractured.The fractured tip was not returned.The shaft is worn such that wear rings are present around the shaft.Discoloration spots were observed on the shaft and handle.The instrument is sporadically nicked and scratched.The device has a potential field age of approximately 1 year and 10 months.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot 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.

Event Description

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

Event Description

No further information at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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
• 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: 11312975
• MDR Text Key: 231355851
• Report Number: 0001825034-2021-00407
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00800304484498
• UDI-Public: (01)00800304484498(11)190405(10)Z18L2492
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Race: White