MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM; BIT,DRILL

Catalog Number 03.010.100

Device Problem Failure to Cut (2587)

Patient Problems Bone Fracture(s) (1870); Injury (2348); No Code Available (3191)

Event Date 01/29/2020

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) 2020 the patient underwent an open reduction internal fixation surgery for a humeral diaphyseal fracture.During distal locking the surgeon could not drill the bone with the drill bit and the radiolucent drive because the patient¿s bone quality was good.The surgeon made a hole opposite of the cortical bone with a gimlet and tried to drill it with the radiolucent drive but was not successful.Finally, the surgeon drilled without the radiolucent drive and inserted a screw.During the surgery, the surgeon found a crack around the insertion site of screw on the cortical bone.The surgery was completed successfully without extra procedure because the screw was fixed properly and the fracture site was stable.The surgery was delayed by less than 30 minutes.Concomitant devices: unk - radiolucent drive (part # unknown; lot # unknown; quantity: 1), unk - gimlet (part # unknown, lot# unknown, quantity 1), unk - screw part # unknown, lot# unknown, quantity 1).This report is for one 3.2 mm three-fluted radiolucent drill bit/ needle point/ 145 mm.This is report 1 of 1 for (b)(4).

• Brand Name: 3.2MM 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 SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 9738416
• MDR Text Key: 180354983
• Report Number: 8030965-2020-01288
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819775374
• UDI-Public: (01)07611819775374
• 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: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/21/2020
• 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
• Patient Age: 23 YR