MAUDE Adverse Event Report: STRYKER SPINE-US ANCHOR C SCREWDRIVER - STRAIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48328500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the screwdriver sheared of in the screw.Broken fragments couldn't be removed.The surgeon tried to drill the piece out with no luck.Next, the surgeon created a hole to insert the removal tool however still unable to remove 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.
Event or Problem Description
It was reported that the tip of the screwdriver sheared of in the screw.Broken fragments couldn't be removed.The surgeon tried to drill the piece out with no luck.Next, the surgeon created a hole to insert the removal tool however still unable to remove 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.* update* the additional information received from sales rep.Indicated about an hour of surgical delay resulted while trying to remove the screw with screwdriver fragment in still.No other adverse consequence to the patient was reported.
Additional Manufacturer Narrative
The additional information received from sales rep.Indicated about an hour of surgical delay resulted while trying to remove the screw with screwdriver fragment in still.No other adverse consequence to the patient was reported.Based on the information received, the reportability updated to malfunction.Updated to product problem.Updated to malfunction.Updated to no consequences or impact to patient.
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 of the returned.Product.Material wear and deformation was identified around the tip.Manufacturing files were reviewed and no revealed anomalies were found.The device was manufactured approximately 5 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 tip of the screwdriver sheared of in the screw.Broken fragments couldn't be removed.The surgeon tried to drill the piece out with no luck.Next, the surgeon created a hole to insert the removal tool however still unable to remove 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.

• Brand Name: ANCHOR C SCREWDRIVER - STRAIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8195959
• Report Number: 0009617544-2018-00304
• Device Sequence Number: 1653076
• Product Code: LXH
• UDI-Device Identifier: 07613327267082
• UDI-Public: 07613327267082
• 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: 48328500
• Device Lot Number: 13F467
• 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