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 Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon starting ratcheting the instrument wasn't disconnecting from the implant and broke.Tight space was observed.The procedure was successfully completed and there are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: upon visual inspection, the tip of the instrument was confirmed to be deformed and the inner shaft was found to be slightly bent.No adverse consequences to the patient was reported.Manufacturing history was reviewed and no issues were identified.The age of the device was found to be more than 13 years.The ifu for instruments states that the instruments may fracture depending on the age of the device, the number of times they are used as well as the precautions taken in handling, cleaning and storage.Conclusion: based on the device inspection and provided information, probable root causes of the reported event are: extensive use of the instrument and normal wear and tear.
Event or Problem Description
It was reported that upon starting ratcheting the instrument wasn't disconnecting from the implant and broke.Tight space was observed.The procedure was successfully completed and there are no reports of adverse consequences 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
• MDR Report Key: 7311386
• Report Number: 0009617544-2018-00058
• Device Sequence Number: 110504
• Product Code: LXH
• UDI-Device Identifier: 07613327267914
• UDI-Public: (01)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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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: 058851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1