MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAILS: FEMORAL; ROD, FIXATION, INTRAMEDULLARY

Device Problem Device-Device Incompatibility (2919)

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

Event Date 08/14/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown nails: femoral/unknown lot.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 in 1991, the patient underwent an unknown surgery by using the ufn (unreamed femoral nail) system at another hospital.On (b)(6) 2020, the patient underwent the removal surgery.During the removal surgery, the surgeon could not engage the extraction screw with the top of the nail.After removing the lateral screws, he removed the nail by making an incision at the distal part.The removal surgery was completed with a sixty (60) minute delay.After the surgery, it was confirmed that product code described in the ufn procedure manual was extraction screw (357.360) but product code in the instrument set box was extraction screw (356.721).Later, it was confirmed that the diameter of the tip of the two devices (356.721 and 357.360) are the same.No further information is available.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity 1).This report is for one (1) unk - nails: femoral.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - NAILS: FEMORAL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 10515383
• MDR Text Key: 215136085
• Report Number: 8030965-2020-06758
• Device Sequence Number: 1
• Product Code: HSB
• 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: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• 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: 08/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention