MAUDE Adverse Event Report: STRYKER SPINE-US ANCHOR C SCREW EXTRACTOR ASSEMBLY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48328625
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348); No Code Available (3191)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw extractor tip was damaged while trying to remove a piece of screwdriver that sheared of in the screw.The surgeon removed the cage and screws by drilling around the implant to free up the screws enough to pull cage out.A surgical delay time has not been specified.
Additional Manufacturer Narrative
Method: visual inspection, functional inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the reported event was confirmed upon visual inspection.The tip of device is deformed and twisted as reported.Manufacturing files were reviewed and no revealed anomalies were found the device was manufactured over 7 years ago.Conclusion: the root cause of the reported event is normal wear and tear due to device age.
Event or Problem Description
It was reported that the screw extractor tip was damaged while trying to remove a piece of screwdriver that sheared of in the screw.The surgeon removed the cage and screws by drilling around the implant to free up the screws enough to pull cage out.A surgical delay time has not been specified.
Additional Manufacturer Narrative
The additional information received from the sales rep confirmed that the rod threads were damaged and resulted in about an hour surgical delay while trying to remove the screw with screwdriver fragments in still.No other adverse consequence to the patient was reported.Based on the additional information, the reportability updated to malfunction.Adverse event : updated to product problem.Type of event: updated to malfunction.Evaluation codes: updated to no consequences or impact to patient.
Event or Problem Description
It was reported that the screw extractor tip was damaged while trying to remove a piece of screwdriver that sheared of in the screw.The surgeon removed the cage and screws by drilling around the implant to free up the screws enough to pull cage out.A surgical delay time has not been specified.The additional information received from the sales rep confirmed that the rod threads were damaged and resulted in about an hour surgical delay while trying to remove the screw with screwdriver fragments in still.No other adverse consequence to the patient was reported.

• Brand Name: ANCHOR C SCREW EXTRACTOR ASSEMBLY
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8196018
• Report Number: 0009617544-2018-00305
• Device Sequence Number: 1653075
• Product Code: LXH
• UDI-Device Identifier: 07613327267181
• UDI-Public: 07613327267181
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 48328625
• Device Lot Number: 113832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 02/11/2019; 03/13/2019
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 03/12/2019; 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other