MAUDE Adverse Event Report: SYNTHES GMBH UNK - ELASTIC NAILS; NAIL, FIXATION, BONE

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

Patient Problems Pain (1994); Numbness (2415); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown elastic nails/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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: braun, k.F.Et al.(2014), functional results following titanium elasticstable intramedullary nailing (esin) of mid-shaft clavicle fractures, acta chirurgiae orthopaedicae et traumatologiae cechosl., vol.81(2), pages 118-121 (germany).The purpose of this retrospective study was to review our functional, radiological and cosmetic results of displaced mid-shaft clavicle fractures treated by esin.A total of 40 patients (10 females and 30 males) with a primary unilateral mid-shaft clavicle fracture (type 15-b according to ota) were treated with a titanium elastic nail (ten ¿ depuysynthes, umkirch, germany).Postoperatively, all patients received a sling for comfort for 14 days after surgery.Active range of motion was limited to 90° of abduction and elevation for 6 weeks.Ten-removal was suggested after the fracture was consolidated at 3 months earliest and 12 months latest.Patients were followed for 13.4 ± 6.9 months postoperatively.The following complications were reported as follows: 12 patients had medial migration which irritated the skin in 3 patients and lead to skin perforation in 2 patients.Therefore 3 patients requested the nail to be removed or locally shortened in local anaesthesia.4 patients had local skin numbness.5 patients had sensoric irritations.5 patients had mild pain.This report is for an unknown synthes ten.This report is for one (1) unk - elastic nails.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - ELASTIC NAILS
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10994582
• MDR Text Key: 221284427
• Report Number: 8030965-2020-09633
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2020
• 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: 11/16/2020
• 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