MAUDE Adverse Event Report: NUVASIVE, INC. MAXCESS 4 ARTICULATING ARM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	3240121
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned to nuvasive for evaluation.Operative notes and/or medical records were not provided for review of usage/technique.A review of manufacturing records was unable to be performed as the lot information of the product involved in the event was not available.A definitive root cause was unable to be determined with the information provided.Labeling review: "pre-operative warnings: the method of use for the instruments are to be determined by the user¿s experience and training in surgical procedures.The instruments should be treated as any precision instrument and should be carefully placed on trays, cleaned after each use, and stored, according to generally accepted hospital methods and practices.The instruments should be carefully examined prior to use for functionality, excessive wear, or damage.A damaged instrument should not be used as this may increase the risk of malfunction and potential patient injury.Instruments should be protected during storage and from corrosive environments.Refer to cleaning and sterilization instructions below for all non-sterile parts.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient" if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that during a procedure, the arm would not fully lock down in order to rigidly maintain retractor placement.The surgeon proceeded with the procedure by holding the retractor in place by hand and was able to successfully insert the cage in the correct position and complete the procedure.There was no report of adverse impact to patient.No additional information is available.
Additional Manufacturer Narrative
The device was returned on july 24, 2023 via in bound set return not on the rma.Examination of the returned device was completed by nuvasive under service qn400218570 where the locking mechanism was found to be worn and sloppy from excessive use and the complaint was confirmed.Device history record review identified the arm was release to the field in 2019.The root cause was determined to be the result of age/wear and excessive use related to 4 years of field use as part of a loaner set and subjected to handling, tightening and repeated sterilization cycles where damage and wear was accumulated.The device was sent out for vendor refurbishing.No additional investigation required.Manufacturing review: review of the device history record notes no material non-conformance, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.Labeling review: "pre-operative warnings: the method of use for the instruments are to be determined by the user¿s experience and training in surgical procedures.The instruments should be treated as any precision instrument and should be carefully placed on trays, cleaned after each use, and stored, according to generally accepted hospital methods and practices.The instruments should be carefully examined prior to use for functionality, excessive wear, or damage.A damaged instrument should not be used as this may increase the risk of malfunction and potential patient injury.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "method of use: if there is any doubt or uncertainty concerning the proper use of instruments, please contact nuvasive customer service.Any available surgical techniques will be provided upon request.For optimal results, the same type of instruments used for implantation should be used for implant removal." "information: to obtain a surgical technique manual or should any information regarding the products or their uses be required, please contact your local representative or nuvasive directly at +1-800-475-9131.You may also email: info@nuvasive.Com.".
Event or Problem Description
New or updated information list in section h10.

• Brand Name: MAXCESS 4 ARTICULATING ARM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd.; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoffrey gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 17491565
• Report Number: 2031966-2023-00165
• Device Sequence Number: 7821782
• Product Code: LXH
• UDI-Device Identifier: 00887517196668
• UDI-Public: 887517196668
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2023

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: 3240121
• Device Lot Number: NS1028783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose