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

Catalog Number	48999000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon was tightening down the screw and the head of the driver broke off.No adverse consequences were reported.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessmentthe reported was confirmed upon visual inspection of the returned device.Broken fragments were retrieved and discarded.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.The device was manufactured 4.5 years ago.The ifu for the device indicates: "while rare, intraoperative fracture or breakage of instruments can occur.Instruments which have experienced extensive use or extensive force are more susceptible to fracture depending on the operative precaution, number of procedures, and disposal attention." conclusion: the plausible root cause of the reported event is normal wear tear due to device age (4.5 years old).
Event or Problem Description
Surgeon was tightening down the screw and the head of the driver broke off.No adverse consequences were reported.

• Brand Name: ANCHOR L SCREWDRIVER MODULAR RIGID
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7853181
• Report Number: 0009617544-2018-00215
• Device Sequence Number: 1445758
• Product Code: LXH
• UDI-Device Identifier: 07613327274905
• UDI-Public: 07613327274905
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2018

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: 48999000
• Device Lot Number: 13A708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1