MAUDE Adverse Event Report: FLOWER ORTHOPEDICS DBK 030; DRILL BIT KIT, 3.0MM

Catalog Number	DBK 030
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The drill bit could not be removed by the surgeon as the surgeon assessed that it would cause increased morbidity to the patient.There is currently a minimum of 0.1mm clearance between the drill bit and drill guide, which could have caused the drill guide to get stuck.Dbk 030 shall be updated to have an increased clearance.
Event or Problem Description
Dbk 030 broke, a piece was left in the patient.According to (b)(6) (sales rep), the drill bit got stuck within the drill guide and because the drill bit was stuck, it warped and a piece of the drill bit was broken off and left within the patient.The surgeon had no interference when inserting the screw where the drill bit broke off and the case went on.

• Brand Name: DBK 030
• Common Device Name: DRILL BIT KIT, 3.0MM
• Manufacturer (Section D): FLOWER ORTHOPEDICS; 100 witmer rd.; suite 280; horsham PA 19044
• MDR Report Key: 8605769
• Report Number: 3009996260-2019-00003
• Device Sequence Number: 2115050
• Product Code: HTW
• UDI-Device Identifier: 00840118104623
• UDI-Public: 840118104623
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 05/13/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: DBK 030
• Device Lot Number: 2014000489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 05/13/2019
• 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
• Patient Age: 31 YR