MAUDE Adverse Event Report: SYNTHES GMBH 1.1MM DRILL BIT/STRYKER J-LTCH WITH 12MM STOP/44.5MM; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	317.22
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.This report is for an unk - drill bits: trauma lot.Part and lot numbers are unknown; udi number is unknown.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.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 or Problem Description
Device report from synthese reports an event in canada as follows: it was reported on (b)(6) 2023, that the dr.Was drilling into the left mandible when the drill bit broke off and the dr.Was unable to retrieve the synthese drill bit 1.1mm from the epen set.A piece remains in the patient's mandible.This report is for one (1) unk - drill bits: trauma.This is report 1 of 1 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.Part # 317.22.Synthes lot # u255398.Supplier lot # u255398.Release to warehouse date # 20 nov 2017.Supplier # (b)(4).No ncrs were generated during production.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the tip of the 1.1 db/stryker j-ltch 12 stop/44.5 has broken off, fragment was not returned for evaluation and no evidence of the device being embedded to patient was provided.Additionally, the cutting flutes of the reported device were found with signs of wear and dullness, consistent with normal and repetitive use over a long period of time.A dimensional inspection for the 1.1 db/stryker j-ltch 12 stop/44.5 was unable to be performed due to post manufacturing damage.The observed breakage of the device was consistent with a random component failure that may have been caused by exposure to unintended loading forces on the drill tip when drilling.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 1.1 db / stryker j-ltch 12 stop/44.5 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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.D2: common device name and procode updated.

• Brand Name: 1.1MM DRILL BIT/STRYKER J-LTCH WITH 12MM STOP/44.5MM
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16685581
• Report Number: 8030965-2023-04195
• Device Sequence Number: 16627211
• Product Code: ERL
• UDI-Device Identifier: 10887587038360
• UDI-Public: (01)10887587038360
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K043310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• 2 Devices were Involved in the Event: 1 2

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 Model Number: 317.22
• Device Catalogue Number: 317.22
• Device Lot Number: U255398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown