MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK PUERTO RICO MFG TOOL LEGEND 10CM 4MM BA DIAM; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	10BA40D
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report confirmed.Evaluation determined that the tool tip was broken and missing.The likely cause was identified as a combination of contact of the tool between a metal object and the tool neck while running, heavy load and/or inadequate irrigation.It was also identified that the broken tool was still used on bone rounding the corners of the tip end.The device user manual warnings section includes instructions to check the device for damage before use.If damage is found, the device should not be used.We will continue to track and trend this complaint type.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the during a fusion surgery at two levels, the surgeon did not notice that the drill broke and continuously drilled a pilot hole into cortical bone.It was reported that during the routine imaging that it was confirmed that the drill tip piece was left in the patient.No patient impact reported.It was also reported that the surgeon tried to retrieve the tip of the tool with forceps however that failed.The surgeon determined removal would cause the patient to lose too much blood and the broken tip was out of insertion route of the screws and the wound was closed.On follow up it was confirmed that there was no patient impact and no additional follow up was required for the patient post surgery.It was also reported that the patient has left the hospital and went home with no further complications reported back to the hospital.

• Brand Name: TOOL LEGEND 10CM 4MM BA DIAM
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909; humacao PR 00792
• MDR Report Key: 7409825
• Report Number: 1030489-2018-00525
• Device Sequence Number: 1030935
• Product Code: HBE
• UDI-Device Identifier: 00643169757622
• UDI-Public: 00643169757622
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K020069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2023
• Device Model Number: 10BA40D
• Device Catalogue Number: 10BA40D
• Device Lot Number: H5410573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2018
• Initial Report FDA Received Date: 04/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other