MAUDE Adverse Event Report: GENESYS SPINE BINARY ANTERIOR CERVICAL PLATING SYSTEM; SCREW DRIVER

Model Number	GCP237
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing paperwork for this lot of parts showed that the grade of steel and heat treatment of the device met all required specifications and was appropriate for the application.Inspection of the returned device showed that the instrument tip yielded prior to breaking - this demonstrates that extremely high forces were applied to the instrument.The minimum material yield strength is 237,000 psi.The cause of failure was a device malfunction attributed to the application of extremely high forces during screw removal.
Event or Problem Description
During an acdf procedure the physician had inserted and secured an anterior cervical plate.The physician wanted to remove one cervical screw and replace it with a different length screw.During screw removal the tip of the removal driver broke off (separated).The physician used a nerve hook [instrument] to retrieve the broken tip of the removal driver.The sales rep stated there were no abnormalities during insertion or removal of the screw prior to the instrument failure.The surgeon reported that the tip of the instrument was retrieved and discarded.There was no effect on the patient, physician, or hospital staff.

• Brand Name: BINARY ANTERIOR CERVICAL PLATING SYSTEM
• Common Device Name: SCREW DRIVER
• Manufacturer (Section D): GENESYS SPINE; 1250 capital of tx hwy south; bld three, ste 600; austin TX 78746
• MDR Report Key: 7042407
• Report Number: 3008455034-2017-00006
• Device Sequence Number: 11225511
• Product Code: KWQ
• UDI-Device Identifier: M719GCP2370
• UDI-Public: +M719GCP2370/$$7WT20160727C
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K133245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

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
• Operator of Device: Health Professional
• Device Model Number: GCP237
• Device Catalogue Number: GCP237
• Device Lot Number: WT20160727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 64