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

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Code Available (3191)

Event Date 12/05/2018

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown drill bit/unknown lot.Part and lot numbers are unknown; udi number is unknown.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).Surgical intervention occurred due to a change in the surgical plan due to not being able to complete the procedure as the intended second screw could not be placed.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

It was reported that on (b)(6) 2018, the patient underwent an open reduction internal fixation (orif) surgery for the humeral surgical neck fracture using multiloc humeral nailing system.During the procedure, the surgeon felt like the drill bit interfered with the proximal humeral nail (phn) when drilling for the distal screw on the proximal side.The surgeon succeeded to drill over to the contralateral bone and re-tightened the connecting screw.Then, when the surgeon drilled for another distal screw on the most distal side, the drill bit strongly interfered with the proximal humeral nail (phn).The surgeon stopped drilling and hammered lightly but could not penetrate the bone.The surgeon gave up drilling and decided to fix with one (1) screw with respect to the distal fixation.The proximal screws and the second distal screw were inserted properly.However, the most distal screw was not inserted.The proximal humeral nail (phn) was left in the patient without the most distal screw.The surgery was delayed by less than 30 minutes due to the reported event.There was no patient outcome reported.Concomitant devices: multiloc screw (part unknown, lot unknown, quantity unknown), connecting screw (part unknown, lot unknown, quantity 1), hammer (part unknown, lot unknown, quantity 1).This report is for one (1) unknown drill bit.This is report 2 of 4 for (b)(4).

• Type of Device: BIT, DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8204060
• MDR Text Key: 131722312
• Report Number: 8030965-2018-59307
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention