MAUDE Adverse Event Report: PRECISION SPINE, INC. REFORM MC SCREW SYSTEM; SCREWDRIVER

Model Number	59-MS-0061
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information - unknown.Other serious (important medical event) - this is being reported as a serious injury (retained foreign object) due to the fractured tip of the driver being left in the head of the lock screw, implanted in the patient.Date of event - unknown.Occupation - other; sales representative.Device evaluation - although information provide indicates that the product is available for evaluation, it has not yet been received.Without the opportunity to evaluate the device, no conclusions can be drawn.Review of device history records found forty-four (b)(4) pieces of lot 00710up were released for distribution on 1/17/2020 with no deviation or anomalies.Two-year complaint history review (5.10.2019-5.10.2021) found this to be the only report for this part number.Should the device be received, a follow-up report will be filed upon completion of evaluation.
Event or Problem Description
It was reported the a procedure was performed on an unknown date, utilizing the reform midline corticle screw system.The doctor was attempting to tighten a lock screw, after it had already been tightened, using the cannulated adjustment driver (59-ms-0061) and torque limiting handle when the tip of the driver broke.The broken tip piece was not able ot be removed and remains in the lock screw, implanted in the patient.According to the distribution the doctor knew it was his fault that the tip broke.There was no delay the procedure reported.
Additional Manufacturer Narrative
H3 device evaluation - the driver's tip is sheared perpendicular to the driver's longitudinal axis, and the remnants of the hexalobe that remain are twisted.The cause for the breakage was acknowledged to be that of the surgeon per his admission.No corrective actions are being recommended since the noted cause is not in agreement with the instrument's intended use.
Event or Problem Description
It was reported the a procedure was performed on an unknown date, utilizing the reform midline corticle screw system.The doctor was attempting to tighten a lock screw, after it had already been tightened, using the cannulated adjustment driver (59-ms-0061) and torque limiting handle when the tip of the driver broke.The broken tip piece was not able ot be removed and remains in the lock screw, implanted in the patient.According to the distribution the doctor knew it was his fault that the tip broke.There was no delay the procedure reported.

• Brand Name: REFORM MC SCREW SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 11931508
• Report Number: 3005739886-2021-00038
• Device Sequence Number: 14532047
• Product Code: HXX
• UDI-Device Identifier: 00840019932448
• UDI-Public: 00840019932448
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 59-MS-0061
• Device Catalogue Number: 59-MS-0061
• Device Lot Number: 00710UP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other