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

Model Number 39-RD-0060

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/20/2022

Event Type  Injury  

Event Description

It was reported that a procedure was performed on (b)(6) 2022, utilizing the reform pedicle screw system.Upon attempted final tightening of the first reform lock screw, the tip of the lock-screw torque driver (39-rd-0060) broke off in the lock screw.The broken tip piece was not able to be removed so it remains in the lock screw implanted in the patient.The procedure was completed utilizing the second lock-screw torque driver readily available in the set.There was no delay to the procedure reported.

Manufacturer Narrative

Patient information - unknown.Outcomes attributed to adverse event: other serious (important medical events) - 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.Initial reporter occupation: other; inventory manager.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.

Manufacturer Narrative

H3 device evaluation - the driver's tip is fractured.The fracture is slightly skewed relative to the driver 's longitudinal axis indicating that both bending moments and torque were both causes for the failure.The fracture surface was examined with the aid of a 5x loop.Three different zones appear to be present.One zone includes a portion that contains some shiny surfaces.It is thought that these surfaces may be at initial crack locations and the shiny surfaces were a result of surfaces rubbing.The other zones appear to be a second failure zone and a final failure zone.Review of device history records found ten (10) pieces of lot 12514ts released for distribution on 3.2.2021 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for the reported part number.The cause for the failure remains unknown but is suspected to be from a prior initiating event that resulted in a crack that manifested in the subsequent failure.No corrective action is recommended at this time.

Event Description

It was reported that a procedure was performed on (b)(6),2022, utilizing the reform pedicle screw system.Upon attempted final tightening of the first reform lock screw, the tip of the lock-screw torque driver (39-rd-0060) broke off in the lock screw.The broken tip piece was not able to be removed so it remains in the lock screw implanted in the patient.The procedure was completed utilizing the second lock-screw torque driver readily available in the set.There was no delay to the procedure reported.

• Brand Name: REFORM PEDICLE SCREW SYSTEM
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive dr; pearl, MS 39208 ; 6014204244
• MDR Report Key: 16174552
• MDR Text Key: 307480211
• Report Number: 3005739886-2023-00004
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00840019928366
• UDI-Public: 00840019928366
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

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
• Device Operator: Health Professional
• Device Model Number: 39-RD-0060
• Device Catalogue Number: 39-RD-0060
• Device Lot Number: 12514TS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 01/16/2023
• Supplement Dates Manufacturer Received: 12/22/2022
• Supplement Dates FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other