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

Model Number	317.32
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the images.The images were reviewed and the complaint condition can be confirmed.The drill bit is broken.A definitive assignable root cause could not be determined based on the provided information.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 during the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot, part # 317.320, lot # f-16443 , manufacturing site:(b)(4), release to warehouse date: (b)(6), supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot 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), the patient underwent for a surgery.During the surgery, while drilling, the drill bit breaks.It was unknown if the surgery completed successfully.The patient outcome was unknown.This complaint involves one (1) device.This report is for (1) 1.1mm drill bit/mini qc with 12mm stop/44.5mm.This report is 1 of 1 for (b)(4).

• Brand Name: 1.1MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM
• Common Device Name: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12339397
• Report Number: 8030965-2021-06819
• Device Sequence Number: 19583673
• Product Code: DZI
• UDI-Device Identifier: 10887587038476
• UDI-Public: (01)10887587038476
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2021

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
• Operator of Device: Health Professional
• Device Model Number: 317.32
• Device Catalogue Number: 317.320
• Device Lot Number: F-16443
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/18/2021
• Patient Sequence Number: 1