MAUDE Adverse Event Report: SYNTHES GMBH FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 04.168.000S

Device Problem Device-Device Incompatibility (2919)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 04/21/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 complainant device 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in (b)(6) as follows: it was reported that the patient underwent first surgery due to garden stage 3 fracture with fns implants in question on march 26, 2021, which is reported in (b)(4).This pc reports about the event in the revision surgery.It was reported that on (b)(6), 2021, displacement of fracture site on femoral neck occurred after the first surgery.On (b)(6) 2021, the patient underwent the revision surgery of removing fns implants and replacing artificial bone head.When the surgeon tried to remove the locking screw by inverting the screwdriver with the insertion handle, the tip of the screwdriver (other company¿s product) broke.Both the plate and the locking screw got difficult to remove.At the discretion of the surgeon, no carbide drill was used, the bone around the plate was excavated.Eventually, the plate and the locking screw were removed rotating the insertion handle forward and reverse repeatedly and replaced with artificial bone head.During the surgery, blood loss increased due to a large incision, and blood transfusion was performed.The surgery was completed successfully with 60 minutes delay.This patient¿s bone head was larger than typical size.The cup used for the artificial bone head was size ¿55¿.The patient had a history of stroke, and due to its sequelae, he had right hemiparesis.The surgeon commented as follows.If it cannot be removed after only 3 weeks after the surgery, there may be a problem with the implant.The preoperative plan of the surgeon for the initial surgery, who is different person from the surgeon for the revision surgery, was insufficient.If the surgeon for the initial surgery was able to recognize that the patient had a large bone head, this event might have been avoided by selecting other implants.In this case, the patient's bone head was very large, which was unexpected, there might be no choice.No further information is available.This report is for one (1) femoral neck system plate 1 hole - sterile this report is 1 of 2 for (b)(4).

• Brand Name: FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES 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
• MDR Report Key: 11852666
• MDR Text Key: 255946367
• Report Number: 8030965-2021-04054
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• 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: 04/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 75