MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM; BIT, DRILL

Catalog Number 03.010.101

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 04/24/2019

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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.(b)(4).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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, an open reduction internal fixation (orif) surgery was performed with multiloc humeral nail (mhn) system for proximal humeral diaphyseal fracture.During insertion of a titanium locking screw for distal side stopping, the surgeon used a drill bit with 4.2mm in diameter, instead of a 3.2mm in diameter.So, the locking screw was inserted into the affected hole which had been created by the drill bit with 4.2mm.However, the surgeon thought that it could not fix the unknown plate with enough force since the hole had been created with the 4.2mm drill bit instead of the 3.2mm.Thus, the locking screw was removed, and the screw was inserted into another hole.The surgery was completed with a 30-minutes delay.The patient is confined in the hospital.There was no adverse consequence reported to the patient.Concomitant devices: (part: unknown, lot: unknown, quantity: 1), locking screw (part: 04.005.414s, lot: 3l10461, quantity: 1).This report is for a 4.2mm three-fluted radiolucent drill bit.This is report 1 of 1 for (b)(4).

• Brand Name: 4.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM
• Type of Device: BIT, DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES MONUMENT; 1101 synthes avenue; monument CA 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8637683
• MDR Text Key: 146062765
• Report Number: 8030965-2019-64465
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819775381
• UDI-Public: (01)07611819775381
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention