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

Catalog Number 04.038.400S

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Type  Injury  

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 an unknown surgery with the tfna nail and the tfna blade.In early (b)(6) 2022, significant displacement of the blade was confirmed by postoperative x-rays.The patient did not complain of pain, so that the surgeon decided to follow up with the patient for observation.On the end of (b)(6) 2022, cut-out was confirmed by x-rays.The patient complained of pain, so a revision surgery was planned.Preoperative x-rays on (b)(6) 2022, showed only a slight cut-out of the tip of the blade in femoral head.However, by preoperative x-rays on (b)(6) 2022, the day of the revision surgery, the blade had displaced further and cut through the pelvis.There were concerns about the failure of the locking mechanism, and the sales rep suggested replacing the nail.However, since the patient had a medical history of heart failure and intraoperative confirmation determined that there was no failure of the locking mechanism, the surgery was completed with the replacement of the 75mm blade.It was confirmed by x-rays that there were no fragments in the patient¿s body.According to the surgeon, the patient has osteoporosis, and the bone is very fragile and shortened excessively.It caused the cut-out in femoral head.The physiotherapist reported the patient was not under excessive load, so that the exact cause for the cut-out in femoral head is unknown.This is report 2 of 2 for (b)(4).This complaint is for tfna blade.

Manufacturer Narrative

Additional narrative: event date: unknown when blade migrated.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is j&j company representative.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.

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.H4 device history part #: 04.038.400s, lot #: 50p5513, manufacturing site: werk selzach, supplier: (b)(4), release to warehouse date: 30 mar 2020, expiration date: 01 mar 2030.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

• Brand Name: TFNA FENESTRATED HELICAL BLADE 100MM - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach NY 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14209940
• MDR Text Key: 290088249
• Report Number: 8030965-2022-02701
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652590
• UDI-Public: (01)07611819652590
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.400S
• Device Lot Number: 50P5513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TFNA FEM NAIL Ø10 R 130° L360 TIMO15; UNK - SCREWS: NAIL DISTAL LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 95 YR
• Patient Sex: Male