MAUDE Adverse Event Report: SYNTHES GMBH 1.1MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM

Model Number	EL-2520S4
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent for an unknown procedure.During the procedure, the drill split.It was unknown if the procedure completed successfully.The patient outcome was unknown.This complaint involves one (1) device.This report is for (1) 1.1mm drill bit/mini qc with 12mm stop/44.5mm.This report is 1 of 1 for (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.H10 additional narrative: h3, h4, h6- product complaint # = > pc-(b)(4).Investigation summary = > 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 history lot = > part number: 317.320 lot number: f-25028 manufacturing site: (b)(4).Supplier: (b)(4).Release to warehouse date: 03.July 2018 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device history batch = > null device history review = > null 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: 1.1MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM
• Common Device Name: DRILL BIT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11166924
• Report Number: 8030965-2021-00286
• Device Sequence Number: 3526673
• Product Code: HTW
• UDI-Device Identifier: 00810633021705
• UDI-Public: (01)00810633021705
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2020

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
• Operator of Device: Health Professional
• Device Model Number: EL-2520S4
• Device Catalogue Number: 317.320
• Device Lot Number: F-25028
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 03/17/2021
• Patient Sequence Number: 1