MAUDE Adverse Event Report: STRYKER SPINE-US AVS PL INSERTER 8 AND 9MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48350951
Medical Device Problem Codes	Fracture (1260); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of an avs pl spacer straight inserter broke off intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.H3 other text : no product returned as there was no problem with device.
Event or Problem Description
It was initially reported that the tip of an avs pl spacer straight inserter broke off intra-operatively.Follow up with the customer representative confirmed that the device was inspected after the procedure and that there was no issue with the device.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.Therefore, this event is no longer reportable to the fda.

• Brand Name: AVS PL INSERTER 8 AND 9MM
• 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: 15161129
• Report Number: 0009617544-2022-00079
• Device Sequence Number: 20299150
• Product Code: LXH
• UDI-Device Identifier: 07613327267914
• UDI-Public: 07613327267914
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2022

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: 48350951
• Device Catalogue Number: 48350951
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 11/01/2022
• 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: Unknown