MAUDE Adverse Event Report: STRYKER SPINE-US AVS TL SPACER INSERTER STRAIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48389100
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an avs tl inserter would not hold the cage intra-operatively.Surgery was successfully completed with another inserter and no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Lot# has been populated in d.4.
Event or Problem Description
It was reported that an avs tl inserter would not hold the cage intra-operatively.Surgery was successfully completed with another inserter and no delay.No adverse consequences or medical intervention were reported.
Event or Problem Description
It was reported that an avs tl inserter would not hold the cage intra-operatively.Surgery was successfully completed with another inserter and no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual inspection: one of the four prongs at the tip fractured off.The inserter is no longer functional with fractured tip.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per the surgical technique, the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.While rare, intraoperative fracture or breakage of instruments can occur.Instruments which have experienced extensive use or extensive force are more susceptible to fracture depending on the operative precaution, number of procedures, disposal attention.Instruments must be examined for wear or damage prior to surgery and after sterilization.The cause of the reported event is normal wear due to device age (11 years).Factors such as consistent use of the instrument throughout its lifetime, cleaning and sterilization may have caused fatigue of the device tip.

• Brand Name: AVS TL SPACER INSERTER STRAIGHT
• 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: 12912870
• Report Number: 0009617544-2021-00226
• Device Sequence Number: 4946259
• Product Code: LXH
• UDI-Device Identifier: 07613327270280
• UDI-Public: 07613327270280
• 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,Followup
• Report Date (Section B): 03/18/2022

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: 48389100
• Device Catalogue Number: 48389100
• Device Lot Number: 107835
• 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: 11/18/2021
• Supplement Date Received by Manufacturer: 12/03/2021; 02/22/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 12/29/2021; 03/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2011
• 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