MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM; REAMER

Catalog Number	357.403
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 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 the patient underwent an unknown surgery using a trochanteric femoral nailing (tfn) system on (b)(6) 2019.During the procedure, the tip of an unknown tfn reamer sheared off inside the patient.It was believed that on inserting the reamer it may have touched the nail hence why the tip of the reamer sheared off.The surgical procedure was successfully competed with no surgical delay.Patient outcome status was unknown.Concomitant device: unknown nail (part # unknown, lot # unknown, quantity 1).This report is for one (1) 6.0mm/10.0mm stepped drill bit cannulated/large qc/435mm.This is report 1 of 1 for (b)(4).

• Brand Name: 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM
• Common Device Name: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8474581
• Report Number: 8030965-2019-62433
• Device Sequence Number: 1629032
• Product Code: HTO
• UDI-Device Identifier: 07611819737709
• UDI-Public: (01)07611819737709
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2019

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 Catalogue Number: 357.403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1