MAUDE Adverse Event Report: PRECISION SPINE, INC. REFORM POCT SYSTEM; ROD PUSHER

Model Number	55-IN-0110
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information - unknown.Occupation - other; distributor.Serious injury - although there was no patient injury or delay to the procedure related to this event, it is being reported as a serious injury due to medical intervention required to remove the broken tip from the patient.Device manufacture date - unknown without lot identification.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2020, "utiilizing" the reform poct system.During normal use of the rod reduction rocker (55-in-0110), the distal end of the instrument broke loose of the shaft and fell into the "paitient".It was retrieved by using a bayonet forcep.No injury to the patient and no real time wasted as a tower reducer was used to finished the job quickly.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2020, utilizing the reform poct system.During normal use of the rod reduction rocker (55-in-0110), the distal end of the instrument broke loose of the shaft and fell into the patient.It was retrieved by using a bayonet forcep.No injury to the patient and no real time wasted as a tower reducer was used to finished the job quickly.
Additional Manufacturer Narrative
H3 device evaluation: evaluation with magnification found that there is a thin weld present.Root cause it attributed to the component diameters being too large, resulting in small seam chamfers that did not allow for enough filler weld, resulting in it being buffed off at finishing.Design changes were introduced in effort to prevent recurrence.Review of device history records found (b)(4) pieces of lot: 00075ptr were released for distribution on 10/9/2018 with no deviation or anomalies.Two-year complaint history review (3.24.2018-3.24.2020) found two previous reports of this nature for this lot.Product from this lot will be reworked.

• Brand Name: REFORM POCT SYSTEM
• Common Device Name: ROD PUSHER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 9898115
• Report Number: 3005739886-2020-00013
• Device Sequence Number: 2238381
• Product Code: LXH
• UDI-Device Identifier: 00840019926546
• UDI-Public: 00840019926546
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/03/2020

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: 55-IN-0110
• Device Catalogue Number: 55-IN-0110
• Device Lot Number: 00075PTR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 08/05/2020
• 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: Required Intervention