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 Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screwdriver tip broke during screw insertion.All broken fragments were retrieved and the procedure as successfully completed with an alternate instrument.There are no reports of adverse consequences to the patient.
Event or Problem Description
It was reported that the screwdriver tip broke during screw insertion.All broken fragments were retrieved and the procedure as successfully completed with an alternate instrument.There are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
The reported event was confirmed via functional inspection.The product was not inspected prior to surgery for wear or damage.Manufacturing files were reviewed and revealed to be over 3 years old with no anomalies found.The instrument was not excessively impacted.The patient had average bone quality.Anchor c surgical technique warns users that extensively used instruments are more susceptible to fracture and must be examined prior to surgery for wear or damage: "instruments which have experienced extensive use or extensive force are more susceptible to fracture depending on the operative precaution, number of procedures, disposal attention.Instruments must be examined for wear or damage prior to surgery." the plausible root cause of the reported event is most likely normal wear and tear.

• 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: 7679312
• Report Number: 0009617544-2018-00168
• Device Sequence Number: 1316112
• Product Code: LXH
• UDI-Device Identifier: 07613327267082
• UDI-Public: 07613327267082
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

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: No Information
• Device Catalogue Number: 48328500
• Device Lot Number: 14E570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1