MAUDE Adverse Event Report: SYNTHES GMBH MATRIXMANDIBLE DRILL BIT 1.5 2FLUTE F/0; GUIDE, SURGICAL, INSTRUMENT

Catalog Number 03.503.476

Device Problem Overheating of Device (1437)

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

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Without a valid lot number the dhr is not available.Complainant device 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.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 europe reports an event in (b)(6) as follows: it was reported that a drill bit and cannula was heating up, as described in previous product complaint: (b)(4).See (b)(4) for details as describe orthognathic.The procedure was successfully completed with only a two minute delay.This report is for one matrixmandible drill bit ¿1.5 2flute f/0.This complaint involves two devices.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.H6: investigation summary: video review: the surgeon believes the drill guide inhibits the ability to cool the drill sufficiently with water irrigation and that this leads to thermal injury to the bone.The surgeon would like the engineers to investigate a solution.Investigation summary: video review: the surgeon believes the drill guide inhibits the ability to cool the drill sufficiently with water irrigation and that this leads to thermal injury to the bone.A customer concern response is not required at this time as all further investigations and actions are documented.Product was not returned.Based on the information available, it has been determined that no corrective and 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: MATRIXMANDIBLE DRILL BIT 1.5 2FLUTE F/0
• Type of Device: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11435449
• MDR Text Key: 243793213
• Report Number: 8030965-2021-01696
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 07611819973176
• UDI-Public: (01)07611819973176
• 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: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.503.476
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CANNULA+OBTURATOR 2; MATRIXMANDIBLE DRILL BIT Ø1.5 2FLUTE F/0