MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK; PLATE, BONE

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint: (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.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2020-00558.Medical products: 1.5mm system high torque (ht),sd,x-dr,scr,5/pk, part# 95-6104, lot# 443850; 1.5mm system high torque (ht),sd,x-dr,scr,5/pk, part# 95-6104, lot# 443760.The user facility is foreign, therefore, a facility medwatch report will not be available.Foreign source: (b)(6).

Event Description

It was reported the screws fractured during insertion.The tips of the screws were found during the operation.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported the screws fractured upon insertion during an extraocular craniotomy.The tips of the screws were found during the operation and no piece of the fractured screws remained in the patient.The procedure was completed with alternate products.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A visual inspection was carried out on the returned 95-6104 screws.The screws show heavy signs of use/ damage.The screw heads on the returned screws have fractured where the screw head meets the screw shaft.There is also damage to the screw threads and screw tips.The complaint is confirmed.Measurements are unable to be performed due to the damage to the screws.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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 further event information available at the time of this report.

• Brand Name: 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10785892
• MDR Text Key: 214771014
• Report Number: 0001032347-2020-00557
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036056650
• UDI-Public: 00841036056650
• Combination Product (y/n): N
• PMA/PMN Number: K121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• 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: 95-6104
• Device Lot Number: 443850
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 36 YR