MAUDE Adverse Event Report: SYNTHES GMBH DRILL BIT Ø1.1 W/STOP L44.5/4; DRILL, BONE, POWERED

Catalog Number 03.503.284

Device Problem Failure to Cut (2587)

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

Event Date 01/29/2022

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.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) 2022, the drill bit were dull and the reduction was lost and the bone was refracted.The wires arrived cut and were too thin for the jaw, they had to use institution wire.This report is for one (1) drill bit ø1.1 w/stop l44.5/4.This is report 6 of 8 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: b5, d4, d9 h3, h4, h6: part 03.503.284, lot u239458: release to warehouse date: november 02, 2016.Supplier: orchid unqiue.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.H3, h6: a product investigation was completed: visual analysis of the returned sample revealed that the drill bit was found to have nicks, also, the blade edges appear to be deformed.Functional issues are most likely due to this condition.The drawings reflecting the current and manufactured revisions were reviewed.A dimensional inspection for the drill bit was unable to be performed due to post manufacturing damage.A functional test was not performed since device functionality cannot be evaluated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the drill bit would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 noted the procedure being performed maxillofacial surgery.The procedure was completed successfully.The patient condition was reported as stable.

• Brand Name: DRILL BIT Ø1.1 W/STOP L44.5/4
• 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 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13636604
• MDR Text Key: 286955468
• Report Number: 8030965-2022-01229
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 07611819994751
• UDI-Public: (01)07611819994751
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.503.284
• Device Lot Number: U239458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2016
• 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: 1.5 DRILL BIT/MINI QC WITH 6 STOP/44.5; 1.5 DRILL BIT/MINI QC WITH 8 STOP/44.5; CERCLWIRE Ø0.4 L150 SST; CERCLWIRE Ø0.6 L175 WITHOUT EYE-SST; DRILL BIT Ø1.1 W/STOP L44.5/6; DRILL BIT Ø1.1 W/STOP L44.5/6; DRILL BIT Ø1.5 L100/85 2FLUTE