MAUDE Adverse Event Report: STRYKER SPINE-US ANCHOR C 12MM DRILL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48328912
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when drilling to create a screw hole, the tip of the drill was broken.The broken piece was all removed.There are no reports of adverse consequences to the patient.
Event or Problem Description
It was reported that when drilling to create a screw hole, the tip of the drill was broken.The broken piece was all removed.There are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
The event was confirmed based on correspondence with the sales rep.The device was not returned for evaluation as it was disposed at the hospital.Device inspection was not performed as the device was not returned.Complaint history review was performed and no similar complaints were identified for the reported lot number.Device history review was performed and no relevant issues were identified.The drill was released in (b)(6) 2015 and is approximately 3.5 years old.The plausible root cause of the reported event cannot be determined conclusively as the device was not returned for evaluation.However, potential root cause of the tip fracture may be: normal wear and tear due to device age and/or user apply too much force when drilling a whole due to hard bone quality.Device not returned.

• Brand Name: ANCHOR C 12MM DRILL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7974578
• Report Number: 0009617544-2018-00240
• Device Sequence Number: 13879660
• Product Code: LXH
• UDI-Device Identifier: 07613327267549
• UDI-Public: 07613327267549
• Combination Product (Y/N): N
• 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): 12/04/2018

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: 48328912
• Device Lot Number: 14F809
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR