MAUDE Adverse Event Report: DEPUYSYNTHES DRILL BIT WITH DEPTH MARK 2.0MM/140MM, DEPUYSYNTHES

Catalog Number 2808.032

Device Problem Crack (1135)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/17/2015

Event Type  malfunction  

Event Description

Type i open left olecranon fracture.During the drilling process, there was very minor chatter at which point the drill was rotated to slowly back this drill out; at which point, there was a crack and the drill was backed out with missing tip of the drill of approximately 1.5-2 cm.C-arm imaging at this point revealed that the drill tip was broken and intramedullary.This was beyond the point of the fracture to the area where it would have been dangerous to remove and as it was felt that this was in stable location with no evidence of causing possible harm to the patient, this was left in place, the risk of removing this broken drill tip would have outweighed any risk of leaving this in.

• Brand Name: DRILL BIT WITH DEPTH MARK 2.0MM/140MM, DEPUYSYNTHES
• Type of Device: DRILL BIT
• Manufacturer (Section D): DEPUYSYNTHES; 800-523-0322
• MDR Report Key: 4953190
• MDR Text Key: 18721442
• Report Number: MW5044914
• Device Sequence Number: 1
• Product Code: HSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 2808.032
• Device Lot Number: DHR194
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 48