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

Model Number 292904201

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/11/2017

Event Type  malfunction  

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 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
• Type of Device: RONGEUR
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6839816
• MDR Text Key: 85620928
• Report Number: 1526439-2017-10728
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 10705034225678
• UDI-Public: (01)10705034225678
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 292904201
• Device Catalogue Number: 292904201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19 YR