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U.S. Department of Health and Human Services

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

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SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 100MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
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.
 
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Brand NameTFNA FENESTRATED HELICAL BLADE 100MM - STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14209940
MDR Text Key290088249
Report Number8030965-2022-02701
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.400S
Device Lot Number50P5513
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/11/2020
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/26/2022 Patient Sequence Number: 1
Treatment
TFNA FEM NAIL Ø10 R 130° L360 TIMO15; UNK - SCREWS: NAIL DISTAL LOCKING
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