MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: NAIL DISTAL LOCKING; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Pain (1994); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown nail/unknown lot.Part and lot numbers are unknown; udi number is unknown.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

This report is being filed after the review of the following journal article: shaheen, e.(2015), tibiotalocalcaneal arthrodesis using a retrograde intramedullary nail for treatment of a posttraumatic ankle disorders in elderly, al-azhar assiut medical journal, vol.13 (3, suppl 1), pages 218-228 (egypt).The purpose of this prospective study was to investigate the outcomes observed in a consecutive series of patients who underwent ttca with an im nail as salvage procedure for posttraumatic ankle disorders in a frail, elderly group of patients.Between (b)(6) 2013 to (b)(6) 2014, a total of 9 patients (5 male and 4 female) with a mean age of 61.4 years (range 50¿75 years), who underwent ttca using intramedullary nails, were included in the study.Surgery was performed using synthes expert hindfoot arthrodesis nail (han; synthes ag, bettlach, switzerland) implant (the im nail).The mean follow-up time was 11.8 months (range 7.5-15 months.The following complications were reported as follows: patient 5: a (b)(6) female patient died 4 months postoperative.This patient had a pre-surgical history of cardiopulmonary disorders with morbid obesity.After his discharge home, his anticoagulant therapy was discontinued at home abruptly at 1 month because of a suspected small intracerebral haemorrhage so pulmonary embolus was diagnosed late.Patient 2: a (b)(6) male patient had a superficial infection with delayed wound healing, requiring local wound care and oral antibiotics.Patient 4: a (b)(6) male patient experienced soft tissue irritation resulting from a prominent distal screw in the calcaneus with painful heel at 5-month follow-up which improved by removal of these screws when obvious union was signed.Patient 6: a (b)(6) male patient had delayed union of ankle or subtalar joints until 6.5 months may be due to poor vascularity, heavy smoking, improper glycemic control with preoperative hemoglobin a1c (hba1c) values of 9.0% and inadequate resection of articular surface of the ankle joint.This report is for an unknown synthes expert hindfoot arthrodesis nail screws.This is report 2 of 2 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - SCREWS: NAIL DISTAL LOCKING
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12128018
• MDR Text Key: 260280236
• Report Number: 8030965-2021-05572
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: EG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR