MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; BIT, DRILL

Device Problem Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown unk - drill bits: trauma/unknown lot.Part and lot number are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.The investigation could not be completed; no conclusion could be drawn.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.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.

Event Description

It was reported that on (b)(6) 2019, a patient underwent an open reduction internal fixation (orif) with expert antigrade femoral nail (afn) for femoral diaphyseal fractures.When the surgeon tried to insert an unknown locking screw for proximal side topping under static transverse mode, an unknown drill bit interfered with an unknown nail.Thus, the surgeon gave up with the static transverse mode and inserted the locking screw under dynamic mode.Eventually, the surgery was completed with no surgical delay.There was no adverse consequence to the patient.Concomitant device reported: unknown locking screw (part# unknown, lot# unknown, quantity 1); unknown afn nail (part# unknown, lot# unknown, quantity 1).This complaint involves two (2) devices.This report is for one (1) unk - drill bits.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

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.

• Type of Device: BIT, DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8406004
• MDR Text Key: 138401940
• Report Number: 8030965-2019-61861
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

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
• Device Operator: Health Professional
• Initial Date Manufacturer Received: 02/14/2019
• Initial Date FDA Received: 03/08/2019
• Supplement Dates Manufacturer Received: 05/06/2019
• Supplement Dates FDA Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1