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

Model Number	48350951
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that an avs pl spacer straight inserter bent intra-operatively.It was further reported via follow up communication that the inserter was used at a difficult angle and excessive force was applied.The procedure was completed successfully using a replacement inserter with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
H6 codes have been updated to reflect receipt of the device and conclusion of the investigation.
Event or Problem Description
A company representative reported that an avs pl spacer straight inserter bent intra-operatively.It was further reported via follow up communication that the inserter was used at a difficult angle and excessive force was applied.The procedure was completed successfully using a replacement inserter with no surgical delay and no adverse consequence to the patient.

• 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: 15693709
• Report Number: 0009617544-2022-00099
• Device Sequence Number: 6763912
• Product Code: LXH
• UDI-Device Identifier: 07613327267914
• UDI-Public: 07613327267914
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/13/2023

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: 127053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2012
• 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