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

Model Number	48389500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during intra-operative placement of a spacer the material of an avs tl inserter broke.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.However, images of the device were provided.One of the prongs that fits into the spacer at the inserter's tip is fractured at half length.Device history records were reviewed for this lot, no relevant manufacturing issues were identified.The device was manufactured in november of 2013 and was in use for approximately 9.5 years.The sales rep indicated that he had this device in his possession since 2016.Complaint history records were reviewed for this catalog number, no adverse trends were identified.Upon follow-up it was confirmed that the disc space did not appear too small for the cage, the disc space was distracted and trialing was performed, the implantation angle was not difficult and no excessive force was applied during implantation.The root cause of the reported event is normal wear and tear.Due to the age of the device, factors such as consistent use of the instrument throughout its lifetime may cause fatigue and contribute to fracture.H3 other text : status and location of the device is unknown.
Event or Problem Description
It was reported that during intra-operative placement of a spacer the material of an avs tl inserter broke.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.

• Brand Name: AVS TL SPACER MIS 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: 14415266
• Report Number: 0009617544-2022-00056
• Device Sequence Number: 5537854
• Product Code: LXH
• UDI-Device Identifier: 07613327270488
• UDI-Public: 07613327270488
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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: 48389500
• Device Catalogue Number: 48389500
• Device Lot Number: 12C441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female