MAUDE Adverse Event Report: BIOMET MICROFIXATION CARROLL-GIRARD SCREW HEX-END; CORKSCREW

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).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 screw fractured during zygomatic fracture reduction.The tip of the remained screw in the patient¿s bone was removed using other device.The surgery was completed using a u type hook and the delay was less than 20 minutes." the following contributing factor related to the event was reported, "the surgeon pulled a screw obliquely in the strong force during procedure." no additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The product was visually evaluated and was seen to be fractured.There is no tissue remaining in the threads.There are no signs of manufacturing defects.The most likely cause of this is excessive force on an off axis angle while attempting to approximate tightly positioned bone fragments.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Investigation results concluded that the reported event was due to excessive force at an off axis angle.Instructions for use (ifu)states: avoid undue stress or strain when handling or cleaning instruments.A summary of the investigation has been sent to the complainant.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.The following was corrected: device manufacture date was corrected from nov 18, 2014 to oct 20, 2014.

• Brand Name: CARROLL-GIRARD SCREW HEX-END
• Type of Device: CORKSCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7172312
• MDR Text Key: 96636544
• Report Number: 0001032347-2018-00015
• Device Sequence Number: 1
• Product Code: HWI
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: SP-2693
• Device Lot Number: 566220
• Other Device ID Number: (01)00841036145491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 01/08/2018
• Supplement Dates Manufacturer Received: 06/13/2018
• Supplement Dates FDA Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR