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 Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a screwdriver tip broke while inserting a screw.The tip was retrieved from the head of the screw and an alternate screwdrivers was used to fully seat the screw.The event resulted in 5 minute surgical delay to retrieve the screwdriver tip.No adverse consequences to the patient were reported.This complaint will be reported as a malfunction.
Additional Manufacturer Narrative
The reported event was confirmed via visual inspection of the returned device.Per visual inspection wear and deformation was identified around broken tip.The device is in the field for over 7 years.Manufacturing files were reviewed and no revealed anomalies were found.The most likely root cause of the tip fracture ifs normal wear due to device age.
Event or Problem Description
It was reported that a screwdriver tip broke while inserting a screw.The tip was retrieved from the head of the screw and an alternate screwdrivers was used to fully seat the screw.The event resulted in 5 minute surgical delay to retrieve the screwdriver tip.No adverse consequences to the patient were reported.

• 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: 7987042
• Report Number: 0009617544-2018-00246
• Device Sequence Number: 1572304
• Product Code: LXH
• UDI-Device Identifier: 07613327267082
• UDI-Public: 07613327267082
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2018

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 Catalogue Number: 48328500
• Device Lot Number: 111873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1