MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: FNS BOLT; APPLIANCE,FIXATION,NAIL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown fns bolt/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.Reporter is a j&j sales representative.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) 2021, the patient underwent removal surgery of femoral neck system (fns) implants and bipolar hip arthroplasty surgery (bha).During the surgery, the surgeon replaced the fns implants with the artificial bone head.The reason bha was performed was shortening of the neck due to oversliding.The surgeon tried to remove a screw with the driver (other company¿s product), the screwdriver broke and was buried on the screw head and it was difficult to remove.After that, the surgeon shaved the area between the screw and the neck bolt by using the carbide drill and removed the neck bolt.The surgeon turned the plate with pliers and removed the screw.The surgery was completed successfully within thirty (30) minutes delay.No further information is available.This report captures the postoperative event of revision procedure due to shortening of the neck while related complaint (b)(4) captures the intraoperative event of screwdriver breakage and was buried on the screw head and it was difficult to remove.This report is for one (1) fns bolt.This is report 2 of 4 for complaint (b)(4).

• Brand Name: UNK - NAIL HEAD ELEMENTS: FNS BOLT
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12564263
• MDR Text Key: 274454721
• Report Number: 8030965-2021-08276
• Device Sequence Number: 1
• Product Code: KTT
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2021
• 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