MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM DRILL BIT/QC WITH 65MM STOP; BIT, DRILL

Catalog Number 388.394

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that during a procedure on (b)(6), 2021, when drilling the lateral mass, the dill bit broke into two pieces.A piece was successfully retrieved from the patient.An x-ray was taken to check all metal fragments had been removed from the patient.No immediate patient harm.This report is for one (1) 2.4mm drill bit/qc with 65mm stop.This is report 1 of 1 for complaint (b)(4).

Event Description

It was further reported that procedure was a posterior cervical fixation.There was a five to ten minute (5-10) surgical delay.

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.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: 2.4MM DRILL BIT/QC WITH 65MM STOP
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11952253
• MDR Text Key: 280537941
• Report Number: 8030965-2021-04640
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819752931
• UDI-Public: (01)07611819752931
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 388.394
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 06/07/2021
• Supplement Dates Manufacturer Received: 06/08/2021
• Supplement Dates FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: CANCELLOUS; UNKNOWN - DRILL GUIDES