MAUDE Adverse Event Report: SYNTHES GMBH DRILL BIT Ø1.8 L125 2FLUTE F/QUICK COUP; DRILL, BONE, POWERED

Catalog Number 310.520S

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/02/2022

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in australia as follows: it was reported on (b)(6) 2022, that dir 83116 received from tga in relation to synthes drill bit 1.8mm length 125mm, 2 flute.Clinical event information: patient underwent surgery to cheek bone and eye.Using a system eight drill a synthes 1.8mm (l-125mm x 2-flute) drill bit broke off into the patients cheek bone.Patient outcome/consequences: drill bit tip (unknown length/depth) was retained in the patients cheek bone.Attempted to remove.Drill bit broke off flush with the patients cheek bone.No further information available as reporter details have not been disclosed (confidential).This report is for one (1) drill bit ø1.8 l125 2flute f/quick coup.This is report 1 of 1 for complaint (b)(4).

• Brand Name: DRILL BIT Ø1.8 L125 2FLUTE F/QUICK COUP
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16148020
• MDR Text Key: 307193102
• Report Number: 8030965-2023-00461
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 07611819770713
• UDI-Public: (01)07611819770713
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.520S
• Device Lot Number: 9086785
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention