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

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

Patient Problem Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - elastic nails: titanium /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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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: this report is being filed after the review of the following journal article: tu k-k et al (2018), intra- and extramedullary fixation combined with vacuum sealing drainage for selective treatment of open tibial fractures: a retrospective case series, int j clin exp med, volume 11(3), pages 2248-2255 (china).The purpose of this study is to introduce this percutaneous intra- and extramedullary fixation (bioef-tens system) + vacuum sealing drainage (vsd) technique and evaluate the results of its application in open fractures of tibia.From january 2011 and june 2013, 15 patients with open tibial fractures were included in this study.There were 11 males and 4 females with a mean age of 41.6 years (range, 16-60 years).These patients were treated with an unknown synthes titanium elastic nails augmented by a competitor¿s unilateral external fixator and a competitor's vacuum sealing drainage.Skin-grafting was done when healthy granulation tissue was proliferated.Flap coverage was required in certain cases where bone was exposed.Follow-up time was at 1 month, 2 months and 3 months postoperatively, and then at 2 months intervals, including clinical and radiographic examinations.The fractures follow-ups were on average 18 months.Complications were reported: a (b)(6) year-old male had an angulation deformity with a coronal angulation in 5° and sagittal angulation in 4°.A (b)(6) year-old male had a delayed union.The consolidation of the fracture and possibility of full weight-bearing was gained by physiotherapy and drug therapy.A (b)(6) year-old female had a delayed union.The consolidation of the fracture and possibility of full weight-bearing was gained by physiotherapy and drug therapy.A (b)(6) year-old male had a delayed union.The consolidation of the fracture and possibility of full weight-bearing was gained by physiotherapy and drug therapy.1 patient had a decrease in ankle joint range of movement by 20-25 percent.This report is for the unknown synthes titanium elastic nails.This report is for (1) unk: elastic nails: titanium.This report is 1 of 5 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11940271
• MDR Text Key: 266666635
• Report Number: 8030965-2021-04594
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 06/04/2021
• 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