MAUDE Adverse Event Report: MIAMI DEVICE SOLUTIONS 2.5MM DRILL

Model Number	MDS111125150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Race is unknown.Investigation: the subject device is not available for inspection.A review of complaint files for the subject device as well as dhr and ncr files using the lot information was conducted.In addition, a sample device from the same lot was tested.All results are filed internally.There were no findings that could have contributed to the event in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed if necessary.
Event or Problem Description
A copy of user facility medwatch report (b)(4) was received in the mail from the fda on (b)(6) 2019.According to the report a drill bit broke.Broken pieces were removed and imaging confirmed no pieces were left in the patient's wound.On (b)(6) 2019, the reporter was contacted via phone and it was confirmed that all pieces were removed and implantation of the proximal humerus plating system was completed using the additional drill bit in the set.No other reports of patient impacts were reported.

• Brand Name: 2.5MM DRILL
• Common Device Name: 2.5MM DRILL
• Manufacturer (Section D): MIAMI DEVICE SOLUTIONS; 7620 nw 25th st ste 3; miami FL 33122
• MDR Report Key: 8936460
• Report Number: 3009222247-2019-00002
• Device Sequence Number: 16774582
• Product Code: HRS
• UDI-Device Identifier: 10812269020487
• UDI-Public: (01)10812269020487(10)BDLY1TS
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K141493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2019

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: MDS111125150
• Device Catalogue Number: MDS111125150
• Device Lot Number: BDLY1TS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 08/27/2019
• 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: 80 YR
• Patient Weight: 85