MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR RETAINING SCREWDRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48770800
Medical Device Problem Codes	Mechanical Problem (1384); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during intra-operative final tightening, 2 aviator retaining screwdrivers could not 'drive the screw into the pocking mechanism on the plate'.Surgery was successfully completed with a 20 minute delay.No adverse consequences or medical intervention were reported.This report captures the second of the two screwdrivers.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.  device history records review could not be performed as a valid lot code was not provided and could not be obtained.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.It is possible that the tip of the driver was worn and that decreased the grip of the screwdriver in the screw head.However, this cannot be confirmed without device inspection and device history record review.The exact root cause cannot be determined from the information provided.Device not returned to stryker.
Event or Problem Description
It was reported that during intra-operative final tightening, 2 aviator retaining screwdrivers could not 'drive the screw into the pocking mechanism on the plate'.Surgery was successfully completed with a 20 minute delay.No adverse consequences or medical intervention were reported.This report captures the second of the two screwdrivers.

• Brand Name: AVIATOR RETAINING SCREWDRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11815518
• Report Number: 0009617544-2021-00085
• Device Sequence Number: 16931142
• Product Code: LXH
• UDI-Device Identifier: 07613327273168
• UDI-Public: 07613327273168
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/25/2021

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: 48770800
• Device Catalogue Number: 48770800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1