MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED SCREW 80MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	04.038.180
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent surgery to implant a tfna in (b)(6) 2022.The nail was removed on (b)(6) 2023 due to a periprosthetic fracture occurring distal to the short tfna.The fracture was noticed along the shaft of the nail.The surgeon suspects that the fracture was there before the nail was placed.During the procedure, the rubber tips on the reaming rod were hard to remove, however they were removed and the surgery was completed successfully.This report involves one tfna fenestrated screw 80mm.This is report 3 of 4 for (b)(4).
Additional 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: additional device product codes: hsb.Implantation date was an unknown day in (b)(6) 2022.Complainant part 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.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.

• Brand Name: TFNA FENESTRATED SCREW 80MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 16797908
• Report Number: 8030965-2023-05188
• Device Sequence Number: 3140364
• Product Code: KTT
• UDI-Device Identifier: 10886982098689
• UDI-Public: (01)10886982098689
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 04.038.180
• Device Catalogue Number: 04.038.180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11/125 DEG TI CANN TFNA 235/LEFT - SILE; 3.0 REAMING ROD/950 STR BALL TIP - SILE; UNK - SCREWS: 5.0 MM LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 56 KG