MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE 2MM STRAIGHT MICROPITUITARY; RONGEUR

Model Number	292904201
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device discarded.
Event or Problem Description
Instrument broke during surgery.Tip left in patient.Per complaint form: surgeon broke off tip of 2mm pituitary from spotlight instrument set in disc space of patient during mis microdiscectomy surgery.Tiny piece was unable to be removed and thus left in patient.X-ray confirmed piece left in l4-l5 disc space.

• Brand Name: 2MM STRAIGHT MICROPITUITARY
• Common Device Name: RONGEUR
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6839816
• Report Number: 1526439-2017-10728
• Device Sequence Number: 1522142
• Product Code: HTX
• UDI-Device Identifier: 10705034225678
• UDI-Public: (01)10705034225678
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2017

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: Physician
• Device Model Number: 292904201
• Device Catalogue Number: 292904201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 09/01/2017
• Patient Sequence Number: 1
• Patient Age: 19 YR