MAUDE Adverse Event Report: STRYKER SPINE-US INSERTION REMOVAL TOOL TRITANIUM TL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48930013
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tritanium tl insertion removal tool "no longer holds the implant and cannot be disassembled" intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully with an 8 minute surgical delay.This record captures the insertion removal tool.
Additional Manufacturer Narrative
There was no reported failure of the device in this record and no observed issues during visual or functional inspections.This device is concomitant as it functioned as intended and did not contribute to reported event.
Event or Problem Description
It was reported that a tritanium tl insertion removal tool "no longer holds the implant and cannot be disassembled" intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully with an 8 minute surgical delay.This record captures the insertion removal tool.

• Brand Name: INSERTION REMOVAL TOOL TRITANIUM TL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13267551
• Report Number: 0009617544-2022-00002
• Device Sequence Number: 13839967
• Product Code: LXH
• UDI-Device Identifier: 07613327376104
• UDI-Public: 07613327376104
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2022

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: 48930013
• Device Catalogue Number: 48930013
• Device Lot Number: 183030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 01/17/2022
• Supplement Report FDA Received Date: 04/12/2022
• 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: Unknown