MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED SCREW 100MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.038.200S

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 the patient initially had a surgery in (b)(6) 2020 and was implanted with short nail.This nail was replaced in (b)(6) 2020 with a long trochanteric fixation nail-advanced (tfna) nail due to breakage.From (b)(6) 2020 the patient had a pain without any new trauma.On (b)(6) 2021, the patient underwent the revision surgery where tfna nail was removed and replaced it with a prosthesis.The removed tfna nail broke after the surgery.Procedure was successfully completed without any surgical delay.This report captures the reported post-operative event of pain.This report is for one (1) tfna fenestrated screw 100mm - sterile.This is report 2 of 4 for (b)(4).

Event Description

The initial complaint was reviewed and found that the tfna is the only complained device.This device is a concomitant device to the event reported on manufacturer report number 8030965-2021-02142.

• Brand Name: TFNA FENESTRATED SCREW 100MM - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11509702
• MDR Text Key: 246974335
• Report Number: 8030965-2021-02088
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652330
• UDI-Public: (01)07611819652330
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• 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: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.200S
• Device Lot Number: 12L1355
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2021
• Patient Sequence Number: 1
• Treatment: TFNA FEM NAIL Ø12 LE 130° L360 TIMO15; UNK - END CAPS: TFNA; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention