MAUDE Adverse Event Report: MSD BARTLETT MFG CRESCENT VB SPACER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	9197006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: 9197006, lot#: 398726.The shaft of the trail handle has broken where the shaft meets the handle locking pin.A microscopic review of the fracture surface is consistent with material overload from a bending moment.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare professional via manufacturer representative regarding a patient with unknown indication for tlif (transforaminal lumbar interbody fusion)(levels implanted l3-s1).It was reported that the instrument broke.The product will be returned and replaced.No further complications were reported.On (b)(6) 2020, update received from rep the product came in patient contact.There were no patient complications.

• Brand Name: CRESCENT VB SPACER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MSD BARTLETT MFG; 2975 brother blvd; bartlett TN 38133
• MDR Report Key: 10940316
• Report Number: 1030489-2020-01741
• Device Sequence Number: 4294750
• Product Code: LXH
• UDI-Device Identifier: 00613994120649
• UDI-Public: 00613994120649
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/03/2020

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: 9197006
• Device Catalogue Number: 9197006
• Device Lot Number: 398726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR