MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - GUIDE/COMPRESSION/K-WIRES; NAIL, FIXATION, BONE

Device Problem Device-Device Incompatibility (2919)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown guide/compression/k-wires.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 right proximal humerus fracture with the multiloc proximal humeral nail in question.The patient¿s medullary cavity was very confined (about 8.8mm measured by computed tomography), and the surgeon managed to insert the nail.The surgeon fixed with unknown 3 screws, and he tried to insert distal locking screws.The surgeon could insert an upper locking screw successfully, but when he tried to drill lower locking hole, a drill bit interfered with the nail.The drill bit seemed to interfere with the lower part of the hole by an image intensifier.The surgeon removed the drill bit, and he tried to drill with a k-wire, but the k-wire interfered with the nail, too.The surgeon disassembled aiming devices, and he drilled the hole.The surgeon could drill and insert a screw, and the surgery was completed successfully.The surgery was delayed by less than 30 minutes.The surgeon commented that the nail might bow because it was inserted very tightly.The patient was in her 80s.Patient outcome is stable.No further information is available.Concomitant device reported: unknown screws ( part# unknown, lot# unknown, quantity 3), unknown distal locking screw ( part# unknown, lot# unknown, quantity unknown), unknown aiming devices ( part# unknown, lot# unknown, quantity 1).This complaint involves three (3) devices.This report is for one (1) unknown guide/compression/k-wires.This is report 3 of 3 for (b)(4).

• Brand Name: UNK - GUIDE/COMPRESSION/K-WIRES
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 9514759
• MDR Text Key: 194155843
• Report Number: 8030965-2019-71410
• Device Sequence Number: 1
• Product Code: JDS
• 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: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• 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: 12/03/2019
• 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