MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - DRILL BITS: TRAUMA; BIT,DRILL

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2019

Event Type  malfunction  

Manufacturer Narrative

Report is for an unknown drill bit/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent open reduction internal fixation surgery for proximal humerus fracture with the aiming arm in question.Before the surgery, the surgeon checked devices, and he found that there was no problem.During the surgery, the surgeon inserted a nail (multiloc short f9.5mm) connected with the aiming arm.The surgeon confirmed that the nail connected to the aiming arm firmly.The surgeon could drill and insert screws into the proximal 3 holes.The surgeon attached a centering sleeve, and he tried to insert the distal screws.The surgeon drilled distal one hole, and he tried to insert a screw, but the screw wasn¿t inserted properly.When the surgeon tried to drill distal second hole, a drill bit moved upward.The surgeon stopped using the aiming arm, and he inserted screws with his hands.The surgery was delayed by thirty (30) minutes.The surgeon commented that the defect cause might be that he applied force to the aiming arm to reduce the fracture part.Procedure was completed successfully.Patient outcome was reported as stable.No further information is available.Concomitant devices reported: nail (part#unknown, lot#unknown, quantity 1), drill (part#unknown, lot#unknown, quantity 1), centering sleeve (part#unknown, lot#unknown, quantity 1).This report is for one (1) unknown drill bit.This is report 2 of 3 for complaint (b)(4).

• Brand Name: UNK - DRILL BITS: TRAUMA
• 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: 9602713
• MDR Text Key: 194637470
• Report Number: 8030965-2020-00441
• 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: 12/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: No
• 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: 12/25/2019
• 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 Age: 70 YR
• Patient Weight: 54