MAUDE Adverse Event Report: SYNTHES GMBH 1.5 DRILL BIT/MINI QC WITH 12 STOP/44.5

Model Number	317.82
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Investigation summary: at the moment of the surgeon performing the drilling in the patient's bone, the drill bit breaks without any force.Leaving the tip inside the patient's bone.Photo investigation: the device was not returned.A photo-investigation was performed on the images.Upon inspecting the images provided, the 1.5 drill bit/mini qc with 12 stop/44.5 was observed to be broken.But the reported embedded condition cannot be confirmed with the information provided 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 history lot: part: 317.820.Lot: f-29924.Manufacturing site: (b)(4).Supplier: (b)(4).Release to warehouse date: mar.23, 2020 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a surgery.During the surgery, when drilling the patient bone, the drill bit break off and leaving the drill tip inside the patient¿s bone.It was unknown if the surgery completed successfully.The patient outcome was unknown.This complaint involves one (1) device.This report is for (1) 1.5 drill bit/mini qc with 12 stop/44.5 this report is 1 of 1 (b)(4).

• Brand Name: 1.5 DRILL BIT/MINI QC WITH 12 STOP/44.5
• Common Device Name: DRILL BIT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11659347
• Report Number: 8030965-2021-02858
• Device Sequence Number: 19712949
• Product Code: HTW
• UDI-Device Identifier: 10887587038773
• UDI-Public: (01)10887587038773
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/16/2021

1 Device was Involved in the Event

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: 317.82
• Device Catalogue Number: 317.820
• Device Lot Number: F-29924
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR