MAUDE Adverse Event Report: SYNTHES GMBH UNK - ELASTIC NAILS: TITANIUM; PIN, FIXATION, SMOOTH

Catalog Number UNK - ELASTIC NAILS: TITANIUM

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2011

Event Type  malfunction  

Manufacturer Narrative

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: kraus tm, et al (2011), elastic stable intramedullary nailing of clavicular midshaft fractures comparison of open vs closed fracture reduction, unfallchirurg, volume 116, pages 102-108 (germany).The aim of the present study was to retrospectively evaluate the functional, radiological and cosmetic outcome after elastically stable intramedullary osteosynthesis for clavicle shaft fractures and to compare the results after open and closed reduction.Over a period of 2.5 years (december 2006 to june 2009), 40 patients with middle third clavicle fractures were included in the study.There were 10 females and 30 males with a mean age of 42.2 +/-13.6 years.There were 19 patients who underwent closed reduction and 21 patients underwent open reduction and intramedullary splinting using elastically stable intramedullary nail (esin).The fractures were stabilized with an unknown synthes titanium elastic nail.Postoperatively, the implant is immobilized in an arm sling for 14 days.Early functional exercise can be performed after wound healing, with elevation and abduction limited to 90° for 6 weeks.Implant removal was performed at a mean of 8+/-7 months (9-44 weeks) after surgery.Follow-up examinations were performed at a mean of 13.4+/-6.9 months postoperatively (period of 3-26 months).Complications were reported as follows: a total of 12 patients had medial migration of the elastic medullary nail.4 patients who had medial migration of nails had no discomfort.3 patients who had medial migration of nails had the nails shortened under local anesthesia because of pain and skin irritation.2 patients who had medial migration of nails had the nails shortened under local anesthesia because of perforation.3 patients who had medial migration of nails had the nails removed because of perforation.These patients had radiologically good osseous coverage.4 patients had paresthesia in the area of the scar and the medial ends of the nail.1 patient had discomfort over the deltoid muscle.5 patients reported minor pain (vas=1).Unknown patients had keloid formation occurred over the entry site of the nail at the medial end of the clavicle.This report is for the unknown synthes titianium elastic nail.This is report 1 of 3 for (b)(4).

• Brand Name: UNK - ELASTIC NAILS: TITANIUM
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 11784552
• MDR Text Key: 249310715
• Report Number: 8030965-2021-03628
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - ELASTIC NAILS: TITANIUM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 05/06/2021
• 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