MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED SCREW 105MM - STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 04.038.205S

Device Problems Break (1069); No Apparent Adverse Event (3189)

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

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Additional device product codes: hsb.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 on an unknown date, the patient¿s nail broke.The patient experienced pain in (b)(6) 2021.A scan was performed on (b)(6) 2021 and the broken nail was discovered at the level of the cephalic screw.On (b)(6) 2021 the patient underwent a revision surgery, the nail was removed and a hip arthroplasty was performed.This report involves one (1) tfna fenestrated screw 105mm - sterile.This is report 3 of 3 for (b)(4).

Event Description

The patient was reported as good.

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.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

It was confirmed that the break occurred to the nail and not to the other devices so the complaint is only on the nail and there is no allegation against the device tfna fenestrated screw 105mm - sterile.

• Brand Name: TFNA FENESTRATED SCREW 105MM - STERILE
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13314876
• MDR Text Key: 284303749
• Report Number: 8030965-2022-00470
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819652347
• UDI-Public: (01)07611819652347
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.205S
• Device Lot Number: 61P8961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 L38 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L38 F/NAILS TAN LIGHT GREEN; TROCHANT FEM NAIL 10 125 L20; TROCHANT FEM NAIL 10 125 L20; UNK - END CAPS: TFNA; UNK - NUTS; UNK - WASHERS
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR