MAUDE Adverse Event Report: SYNTHES GMBH DRILL BIT ø1.8 L90 F/03.503.044; DRILL, BONE, POWERED

Catalog Number 03.503.461S

Device Problems Defective Device (2588); Device-Device Incompatibility (2919)

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

Event Date 08/14/2023

Event Type  malfunction  

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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

It was reported on (b)(6) 2023, that the proplan guide for the case recommended a 1.8 drill bit with the drill guide for the pre-drill cylinders.They had opened a 1.8 drill and this guide.When we mounted the drill on the power tool (they use a stryker handpiece, if this is relevant), there seemed to be a lot of toggle on the drill bit without a guide before inserting into the template, and also the drill bit was far too short with the drill guide.Some of these screws recommended were 16mm and 18mm in length, and if you looked at the length of the drill when placed into the guide, it looked like the drilling length would reach a maximum of 10mm.The two surgeons involved in the case were unhappy with the amount of toggle first on the drill and also that the length didn¿t reach long enough when using the guide.The case went well enough apart from these issues.Unfortunately, the tumor had extended into the mandible.So it had to freehand some of the left side of the mandible.The surgeon managed to utilize two of the screw holes on this side through the guide but then had to bring in some extra fibula and burr the bone to adapt to the plate.There were a few minutes of surgical delay due to the reported event.The surgery was successfully completed.Patient status and outcome: no adverse events were reported.Concomitant device reported: unk - screws: trauma (part# unknown; lot# unknown; quantity: unknown).This report is for one (1)drill bit ã¸1.8 l90 f/03.503.044.This is report 2 of 4 for complaint (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.H3, h4, h6: part # 03.503.461s, lot # 9l51377, manufacturing site: werk selzach logistik, release to warehouse date: 20 jun 2022, expiration date: 01 jun 2032, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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: DRILL BIT ø1.8 L90 F/03.503.044
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO ; SZ
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17765778
• MDR Text Key: 323628650
• Report Number: 8030965-2023-11749
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 10887587012933
• UDI-Public: (01)10887587012933
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.503.461S
• Device Lot Number: 9L51377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• 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: MATRIXMANDIBLE TRCR DRILL GUIDE 397.213; UNK - GUIDES/SLEEVES/AIMING; UNK - SCREWS: TRAUMA