MAUDE Adverse Event Report: SYNTHES GMBH 4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION; BIT, DRILL

Catalog Number 03.010.061

Device Problem Material Integrity Problem (2978)

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

Event Date 04/06/2021

Event Type  malfunction  

Manufacturer Narrative

Part: 03.010.061.Lot: 5l94436.Manufacturing site: (b)(4).Release to warehouse date: 11.October 2019.A manufacturing record evaluation was performed for the finished device lot and no non-conformances related to malfunction were identified.Photo investigation: the device was not returned.A photo-investigation was performed on the images.Upon inspecting the images provided, the drill bit ø4.2 calibr l340 3flute f/03.0 was observed to be broken at the distil end.Thus, the reported complaint condition is confirmed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition is being confirmed during photo/video investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that the drill bit and depth gauge were damaged during surgery.This report is for one (1) 4.2mm three-fluted drill bit qc/330mm/100mm calibration.This is report 1 of 2 for (b)(4).

• Brand Name: 4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11814946
• MDR Text Key: 251468334
• Report Number: 8030965-2021-03882
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819760899
• UDI-Public: 07611819760899
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2021

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: 03.010.061
• Device Lot Number: 5L94436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2019
• 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