MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG LEGEND DISSECTING TOOL; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	10BA30DC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusion can be drawn.The tool has been returned and analysis is pending.This is a known failure mode that could occur due to excessive pressure, such as bending or prying, on dissecting tools.The user manual contains the following warning ¿do not use excessive pressure, such as bending or prying, on attachments or dissecting tools.This may cause tool to bend or break and cause injury to patient, operator and/or operating room staff.¿ 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 (b)(6) midas diamond tool bur diamond coating peeled off, and it was dropped in patient body.Surgeon tried to remove but he was not able to remove all of fragments.So, a part of diamond coating is remaining in patient body.It was reported that there was a 10 minute delay in the surgical procedure.The procedure was completed using back up products.It was also reported the patient was ¿alive: no injury¿.It was noted that a few broken pieces remained in the patient¿s facia and subcutis under x-ray images.The physician determined that the site where the broken piece remained in the body was not a place to give a health hazard to the patient, the physician would not re-open the incision.
Additional Manufacturer Narrative
Report confirmed.Evaluation determined that the diamond coating had detached from the tool.There was galling on the neck near the head and on the head.The galling indicates a metal object came into contact with the tool while it was spinning.The most likely cause of the coat peeling off is a metal object contacting the coating at the back of the tool head, fracturing and peeling the coating from the head.If information is provided in the future, a supplemental report will be issued.

• Brand Name: LEGEND DISSECTING TOOL
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 7158191
• Report Number: 1030489-2018-00002
• Device Sequence Number: 100416
• Product Code: HBE
• UDI-Device Identifier: 00643169757561
• UDI-Public: 00643169757561
• 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,Followup
• Report Date (Section B): 01/30/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/10/2022
• Device Model Number: 10BA30DC
• Device Catalogue Number: 10BA30DC
• Device Lot Number: H5372341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 01/02/2018
• Supplement Report FDA Received Date: 01/30/2018
• 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