MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE; APPLIANCE,FIXATION,NAIL

Catalog Number 04.168.000S

Device Problem Device-Device Incompatibility (2919)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Date 04/11/2019

Event Type  Injury  

Manufacturer Narrative

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 during a removal surgery due to implant cut out, the unknown locking screw cannot be rotated.Initially, the patient had a femoral neck system (fns) implantation on an unknown date of (b)(6) 2019.While the surgeon was trying to remove the implants, the unknown locking screw will not rotate.Thus, it could not be removed from the femoral neck system (fns) plate.The surgeon cut the head of the unknown locking screw with the unknown drill bit, then, removed the plate.The surgeon then removed the unknown locking screw with an unknown extraction tool.Hence, the surgeon replaced the fns implants with an artificial bone head.There was a surgical delay of more than thirty (30) minutes.Also, there was a larger amount of bleeding than expected due to the delay in the operation.As per surgeon, there was a causal relationship between the event and the devices.The surgeon would also like to know the possible reason for this event since in the past the surgeon never experienced that adhesion between a plate and a screw which occurred two (2) months after the surgery.Patient and procedure outcome were unknown.This report captures the intraop event that occurred during removal surgery, while post-op event of implant cut-out is captured under related complaint (b)(4).This report is for one (1) femoral neck system plate 1 hole - sterile.This is report 1 of 2 for complaint (b)(4).

• Brand Name: FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8596528
• MDR Text Key: 144596053
• Report Number: 8030965-2019-63719
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07612334089687
• UDI-Public: (01)07612334089687
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172872
• 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: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.168.000S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2019
• 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