MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH DRILL BIT F/LATERAL CORTEX OPENING F/DHS; BIT, DRILL

Catalog Number 03.037.021

Device Problem Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Device is an instrument and is not implanted/explanted.Product investigation is not yet 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.

Event Description

During insertion of the drill over the k-wire for a proximal femur nail procedure, a k-wire was cut by a drill bit.The surgeon used another set to complete the surgery.This complaint involves one (1) device.This report is for a drill bit.(b)(4).

Manufacturer Narrative

Additional narrative: device was used for treatment, not diagnosis.Patient age was listed between ages 40-50, patient is male patient identifier, date of birth, age and weight not available for reporting.Updated event description, updated concomitant devices.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) s as follows: it was reported during a proximal femur nailing on (b)(6) 2017, a k wire sheared off intraoperatively.During insertion of the drill over the k-wire, the k-wire was cut through by the drill.Back up instrumentation was used to complete the surgery successfully.A fifteen (15) minute surgical delay was reported.Concomitant devices: drill bit (part # 03.037.022, lot # f-16763, qty 1), insertion handle (part # 03.037.011, lot # 8921813, qty 1), connecting screw (part # 03.037.010, lot # 9219128 qty 1), aiming arm (part # 03.037.114, lot # l178546 qty 1), trocar (part # 03.037.019, lot # 9079765, qty 1), aiming arm locking device (part# 03.037.015, lot # l122025, qty 1), compression nut (part # 03.037.016, lot # 8947771, qty 1), guide wire sleeve (part # 03.037.018, lot # 8901948, qty 1), screw guide sleeve (part # 03.037.017, lot # 9066435, qty 1), guide wire (part # 356.830, lot # l572079 or l572078, qty 1).

Manufacturer Narrative

Additional narrative: concomitant therapy date: (b)(6) 2017.A device history record (dhr) review was performed for part number: 03.037.021, synthes lot number: f-16752: manufacturing location: (b)(4), supplier: (b)(4).Release to warehouse date: 26 june 2014: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was performed.The tip and cutting edges of the returned drill bit 03.037.021 presents normal signs of use, there are no signs of excessive wear.The review of the device history record revealed that this instrument was manufactured in june 2014 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.A function check with the returned instruments was performed and didn¿t show any abnormalities.The assembly of the instruments did work as intended.The guide wire is guided through drill sleeve (03.037.018); this ensures the correct alignment of the guide wire.The trocar has no influence onto the alignment.Neither a product nor a function fault could be detected.Although the exact cause cannot be determined, this complaint condition is likely a result of method of use.Lateral strain during use might have caused a slight bending of the guide wire and foster the drill bit to cut into the wire.Based on the investigation findings, 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.

Event Description

Further it was reported that the tip of the guide wire was not left behind in the patient, the tip was removed from the patient and was discarded.

• Brand Name: DRILL BIT F/LATERAL CORTEX OPENING F/DHS
• Type of Device: BIT, DRILL
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7178420
• MDR Text Key: 96862844
• Report Number: 8030965-2018-50214
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819642478
• UDI-Public: (01)07611819642478(10)F-16752
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.021
• Device Lot Number: F-16752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Date Manufacturer Received: 02/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1