MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: TRAUMA; SCREW,FIXATION,BONE

Device Problem Migration (4003)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/24/2023

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: this report is for an for unk - screws: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.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.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.X-ray evidence provided shows a nail and screw construct at the left femur with signs of bone breakage at the distal section near the lateral epicondyle.The most distal screw appears to have backed out from original positioning since x-ray comparison confirms that the screw has shifted outwards in relation to immediate post-op image (right side).As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for unk - screws: trauma.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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

It was reported that, on (b)(6) 2022, the patient was treated acutely with rfna for periprosthetic fracture of distal femur.During the post-op, it was found the one of the screw was backed out.No removal/revision of hardware is involved.No patient consequences reported.This report is for one (1) unk - screws: trauma.This is report 1 of 1 for complaint (b)(4).

• Brand Name: UNK - SCREWS: TRAUMA
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16371986
• MDR Text Key: 309489803
• Report Number: 8030965-2023-01789
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• 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: 01/24/2023
• 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
• Treatment: RFNA/ 12MM/ 360MM/ STANDARD BEND/ STER.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female