MAUDE Adverse Event Report: STRYKER SPINE-US ANCHOR L SCREWDRIVER MODULAR FLEXIBLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48994000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the flexible screwdriver broke.There was no surgical delay, all broken fragments were retrieved, and the procedure was completed successfully.No adverse consequences to the patient were reported.
Event or Problem Description
It was reported that the tip of the flexible screwdriver broke.There was no surgical delay, all broken fragments were retrieved, and the procedure was completed successfully.No adverse consequences to the patient were reported.
Additional Manufacturer Narrative
Method: visual inspection, functional analysis, material analysis, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the reported event confirmed upon visual inspection of the returned device.The screwdriver fractured during last screw insertion.Complaint history was reviewed and no similar complaints were identified for the reported lot number.Dhr history was reviewed, and all released units met specification.A material analysis (mar) was performed on the returned device.Per mar the tip was found to have fractured in a mixed mode of cleavage and ductile fracture due to an applied reverse bending load.The elemental constituents and measured hardness were found to be in compliance with the print.No material or manufacturing defects were found.It was reported that the screw was implanted at difficult angle at l5-s1 level.Conclusion: the plausible root cause of the reported event is fracture due to applied reverse bending load most likely due to difficult implantation angle and challenging l5-s1 level.

• Brand Name: ANCHOR L SCREWDRIVER MODULAR FLEXIBLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7993741
• Report Number: 0009617544-2018-00247
• Device Sequence Number: 13766865
• Product Code: LXH
• UDI-Device Identifier: 07613327274578
• UDI-Public: 07613327274578
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 01/31/2019

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: No Information
• Device Catalogue Number: 48994000
• Device Lot Number: 167806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1