MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DRILL BIT Ø4 F/PFNA; BIT, DRILL

Catalog Number 356.834

Device Problem Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.Reporter¿s phone number is unknown.(510k): device is not distributed in the united states, but is similar to device marketed in the usa.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, during a surgery to treat the sub-trochanteric fracture, the drill hit a nail at the time of drilling after the drill sleeve was inserted into the aiming arm.The surgeon successfully completed the surgery by adjusting the drill angle slightly.The operation was delayed by five (5) minutes and there were no adverse consequences for the patient.Surgeon commented that the connecting screw, insert handle and other parts were firmly connected and bending of the nail was not seen inside the bone.This report is for one (1) drill bit ø4 f/pfna.This is report 5 of 5 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device history records review was completed for part# 356.834, lot# l355224.Manufacturing location: bettlach, release to warehouse date: may 05, 2017.No non- conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product development investigation was completed.The received part has signs of use on its surface.The exact root cause could not be determined as no detailed clinical information and not all involved parts, especially the involved nail, were provided.In addition, complained malfunction could not be reproduced as the device passed the required functional check at customer quality department successfully.The functionality test was performed in collaboration with product development department and with all received parts for this complaint and the corresponding equipment.Due to functional test results, this complaint will be rated as unconfirmed.Incorrect handling of the equipment could have led to the issue, e.G.Was not mounted correctly.The cause of failure is not due to any manufacturing non-conformance.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.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.

• Brand Name: DRILL BIT Ø4 F/PFNA
• Type of Device: BIT, DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7282421
• MDR Text Key: 100656862
• Report Number: 8030965-2018-51229
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819291126
• UDI-Public: (01)07611819291126(10)L355224
• 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: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 356.834
• Device Lot Number: L355224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Date Manufacturer Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1