MAUDE Adverse Event Report: SYNTHES GMBH DRILL BIT Ø1.1 W/STOP L44.5/6 2FLUTE; DRILL, BONE, POWERED

Catalog Number 317.160

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/28/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, the patient underwent the open reduction internal fixation surgery for infraorbital margin with two drill bits in question.In the surgery, two drill bits were broken.The fragment of one of the broken two drill bits might be left in the patient's body.No broken fragment was found during the surgery, and when ct was performed after the wound was closed, a shadow suggesting it was seen.The surgery was completed successfully with 40 minutes delay.The surgeon will perform a reoperation and remove the broken drill fragment on an unknown date.No further information is available.This report is for two (2) drill bit ø1.1 w/stop l44.5/6 2flute.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Reporter is a j&j employee.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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.

• Brand Name: DRILL BIT Ø1.1 W/STOP L44.5/6 2FLUTE
• 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: 14594453
• MDR Text Key: 293283825
• Report Number: 8030965-2022-03663
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 07611819020542
• UDI-Public: (01)07611819020542
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 317.160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2022
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: DRILL BIT Ø1.1 W/STOP L44.5/6 2FLUTE
• Patient Outcome(s): Required Intervention