MAUDE Adverse Event Report: SYNTHES GMBH UNK - DRILL BITS: CMF

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/09/2021

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown drill bits: cmf/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, during a procedure the mandible cutting guides sat too high and required additional dissection through the gums.The left mandible plate uses 4mm screw for holes six (6) and seven (7), and during the pre-drilling the screws for the plate, it was difficult to identify which drill bit size should be used through the pre drill cylinders.The left cutting guide was also off by 3mm which resulted in surgeon having to freehand the cut to account for the error with the planning.The genioplasty all went to plan.There was no surgical delay.The patient outcome was good.This report involves one (1) unknown drill bits: cmf.This is report 2 of 2 for (b)(4).

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.A1: additional patient identifier: me21 dex dfj.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: UNK - DRILL BITS: CMF
• Type of Device: DRILL BIT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11783220
• MDR Text Key: 249259652
• Report Number: 8030965-2021-03603
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• 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: 04/09/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2021
• Initial Date FDA Received: 05/06/2021
• Supplement Dates Manufacturer Received: 08/15/2021
• Supplement Dates FDA Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRUMATCH MDFC/MND TI 3D PRNT GUD/MND; UNK - SCREWS: CMF; UNKNOWN MANDIBLE CUTTING GUIDES; UNKNOWN MANDIBLE PLATE; TRUMATCH MDFC/MND TI 3D PRNT GUD/MND; UNK - SCREWS: CMF; UNKNOWN MANDIBLE CUTTING GUIDES; UNKNOWN MANDIBLE PLATE
• Patient Outcome(s): Required Intervention