MAUDE Adverse Event Report: SYNTHES GMBH 12MM/125 DEG TI CANN TFNA 200MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.037.213S

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

Patient Problems Bone Fracture(s) (1870); Swelling/ Edema (4577)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.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 reports an event in (b)(6) as follows: it was reported that on june, the patient underwent the surgery for trochanteric fracture of femur with the tfna nail.On july 30, the patient had a re-fracture when he tried to massage his thigh to remove swelling.He has sequelae of spinal injury and cannot move lower extremities.On august 2, the revision surgery will be performed removing the implants and using a longer nail and cement.This report is for one (1) 12mm/125 deg ti cann tfna 200mm - sterile.This is report 1 of 3 for complaint (b)(4).

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.H3, h4, h6: part # 04.037.213s synthes lot # h809996 supplier lot # n/a release to warehouse date: 15 jan 2019 expiration date: 01 jan 2029 manufacturing location: monument no ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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.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: 12MM/125 DEG TI CANN TFNA 200MM - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12379855
• MDR Text Key: 268557520
• Report Number: 8030965-2021-07305
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982097033
• UDI-Public: (01)10886982097033
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

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
• Device Operator: Health Professional
• Device Model Number: 04.037.213S
• Device Catalogue Number: 04.037.213S
• Device Lot Number: H809996
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 09/02/2021
• Supplement Dates FDA Received: 10/01/2021
• Patient Sequence Number: 1
• Treatment: UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: NAIL DISTAL LOCKING
• Patient Outcome(s): Required Intervention