MAUDE Adverse Event Report: UNKNOWN_INSTRUMENTS_PRODUCT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number UNK_INS

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

Device not returned for evaluation.

Event Description

It was reported via medwatch mw5101092 that during an orif (open reduction and internal fixation) surgical procedure, the drill bit broke while surgeon was actively drilling.It was also reported that the broken drill bit piece was lodged into the patient¿s bone.It was further reported that the surgeon was able to extract the broken piece, an x-ray confirmed successful removal.

Manufacturer Narrative

Follow-up report submitted to document device evaluation results.H3 other text : device not returned for evaluation.

Event Description

It was reported via medwatch mw 5101092 that during an orif (open reduction and internal fixation) surgical procedure, the drill bit broke while surgeon was actively drilling.It was also reported that the broken drill bit piece was lodged into the patient¿s bone.It was further reported that the surgeon was able to extract the broken piece, an x-ray confirmed successful removal.

• Brand Name: UNKNOWN_INSTRUMENTS_PRODUCT
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• MDR Report Key: 12131915
• MDR Text Key: 260439605
• Report Number: 0001811755-2021-00778
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_INS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention