MAUDE Adverse Event Report: BIOMET MICROFIXATION CARROLL-GIRARD SCREW HEX-END; CORKSCREW, ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 03/23/2017

Event Type  Injury  

Manufacturer Narrative

A photograph was provided which confirms the device is fractured.The user facility is foreign; therefore a facility medwatch report will not be available.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported during an open reduction and internal fixation for zygomatic arch procedure a screw broke.The remaining screw was removed using a diamond bar.A surgical delay over 30 minutes was reported, however the exact delay is unknown.The patient did not retain a foreign body.

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Manufacturer Narrative

The product identity was confirmed in the evaluation.The product was visually evaluated and was seen to be fractured.There is a slight bend leading into the fracture sight which is expected as there was plastic deformation just prior to fully fracturing.There is tissue remaining in the threads, but the thread form is clean with the exception of the areas affected during removal with the diamond bar.The most likely cause of this is determined to be excessive force on an off axis angle while attempting to approximate tightly positioned bone fragments.Instructions for use state, "avoid undue stress or strain when handling or cleaning instruments." the non-conformance database was reviewed and there are no non-conformances associated with this product.

• Brand Name: CARROLL-GIRARD SCREW HEX-END
• Type of Device: CORKSCREW, ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6586120
• MDR Text Key: 75815406
• Report Number: 0001032347-2017-00404
• Device Sequence Number: 1
• Product Code: HWI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2017

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SP-2693
• Device Lot Number: 655320
• Other Device ID Number: (01)00841036145491(10)655320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2017
• Initial Date FDA Received: 05/23/2017
• Supplement Dates Manufacturer Received: Not provided; 07/27/2017
• Supplement Dates FDA Received: 06/06/2017; 07/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention