MAUDE Adverse Event Report: SYNTHES GMBH 1.5MM DRILL BIT/MQC FOR GLIDING HOLE/48MM; BIT, DRILL

Catalog Number	03.130.212
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter is synthes sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 an unknown date, during an unknown procedure, the drill bit broke.The tip remained inside the patient.No further information provided.This report is for one (1) 1.5mm drill bit/mqc for gliding hole/48mm.This is report 1 of 1 for (b)(4).

• Brand Name: 1.5MM DRILL BIT/MQC FOR GLIDING HOLE/48MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10717773
• Report Number: 8030965-2020-08106
• Device Sequence Number: 3141126
• Product Code: HTW
• UDI-Device Identifier: 07611819690639
• UDI-Public: (01)07611819690639
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• 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): 09/26/2020

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 Catalogue Number: 03.130.212
• Device Lot Number: F-20599
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 11/25/2020
• 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