MAUDE Adverse Event Report: SYNTHES GMBH MATRIXMANDIBLE THREADED TROCAR DRILL GUIDE FOR 397.213; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.503.047
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that the drill bit bent and caused burns to the patient.Two (2) other drill bits were tried and did not bend but heated to a point of causing the burns, upon inspection it seems that the drill sleeve has a slight bend in it.The procedure was completed successfully.This report is for one (1) matrixmandible threaded trocar drill guide for 397.213.This is report 2 of 4 for (b)(4).
Additional 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.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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 THREADED TROCAR DRILL GUIDE FOR 397.213
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• MDR Report Key: 12175943
• Report Number: 8030965-2021-05796
• Device Sequence Number: 11013310
• Product Code: FZX
• UDI-Device Identifier: 07611819894396
• UDI-Public: 07611819894396
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.503.047
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MATRIXMANDIBLE DRILL BIT Ø1.5 2FLUTE F/0; MATRIXMANDIBLE DRILL BIT Ø1.5 2FLUTE F/0; MATRIXMANDIBLE DRILL BIT Ø1.5 2FLUTE F/0
• Outcome Attributed to Adverse Event: Required Intervention