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

Model Number	48328550
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	05/14/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screwdriver tip broke during screw tightening.All fragments were retrieved and the procedure was successfully completed with a new driver.There were no adverse consequences to the patient.
Event or Problem Description
It was reported that the screwdriver tip broke during screw tightening.All fragments were retrieved and the procedure was successfully completed with a new driver.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, labelling review, risk assessment result: the reported event of the flexible screwdriver fracture was confirmed via visual inspection.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.The device was determined to be approximately 5 years old.Surgical technique guide warns users that extensive use of the instrument leaves it more susceptible to fracture.Instruments must be examined prior to surgery for wear or damage.In this case it was reported that the instrument was not inspected prior to a surgery.Conclusion: the plausible root cause of the reported event was determined conclusively to be normal wear and tear due to the age of the instrument and indications of excessive use.

• Brand Name: ANCHOR C SCREWDRIVER - FLEXIBLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7572737
• Report Number: 0009617544-2018-00132
• Device Sequence Number: 19458187
• Product Code: LXH
• UDI-Device Identifier: 07613327126273
• UDI-Public: (01)07613327126273
• 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): 08/28/2018

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 Model Number: 48328550
• Device Catalogue Number: 48328550
• Device Lot Number: 12C172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1