MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ALIF TRIAL SPACER RASP-QUICK RELEASE 13MM HEIGHT

Model Number	03.808.104
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2021, during a & p lumbar fusion, while preparing the endplate for implant, one of the rasps broke at the distal end, allowing the head to flop freely around.Another backup syncage rasp tray, that was kept in the room during alif procedures, was opened.There was a surgical delay of two (2) minutes.The procedure was successfully completed.No patient consequence.This report involves one (1) alif trial spacer rasp-quick release 13mm height.This is report 1 of 1 for (b)(4).

• Brand Name: ALIF TRIAL SPACER RASP-QUICK RELEASE 13MM HEIGHT
• Common Device Name: RASP
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11671019
• Report Number: 2939274-2021-01854
• Device Sequence Number: 11720604
• Product Code: HTR
• UDI-Device Identifier: 10705034724393
• UDI-Public: (01)10705034724393
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

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: 03.808.104
• Device Catalogue Number: 03.808.104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1