MAUDE Adverse Event Report: SYNTHES GMBH UNK - ELASTIC NAILS: TITANIUM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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

Patient Problems Wound Dehiscence (1154); Discomfort (2330); Non-union Bone Fracture (2369); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown 2.0 to 3.0 mm ten/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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: park j.S., (2020)plate fixation versus titanium elastic nailing in midshaft clavicle fractures based on fracture classifications, journal of orthopaedic surgery volume 28(3), pages 1¿11 (korea, south) doi: 10.1177/2309499020972204.This retrospective study aims to determine the optimal strategy for implant selection by comparing plates and tens with respect to outcomes and related complications and to analyze the results based on fracture patterns.From january 2015 to june 2018, 151 consecutive patients with midshaft clavicular fractures (mcfs) who underwent internal fixation with plate or ten were retrospectively reviewed.A total of 97 patients with mcfs who met the study criteria were evaluated in our study.The patients were divided into two groups based on the fixation method: plate performed in 48 patients (40 males, 8 females) with mean age at injury 41.5 + 13.6 (21¿60 years , range) using the 3.5 mm locking compression plate (depuy synthes, in, usa) and ten performed in 49 patients (34 male,15 females) with mean age at injury 36.5 + 13.7 (16¿57 years , range) using the 2.0 to 3.0 mm ten (depuy synthes, pa, usa).Patient follow-up in the outpatient clinic with radiographs occurred at 2, 6, and 12 weeks and 6 and 12 months after surgery.At 12 months after implantation, if the fracture was completely healed, removal of the implant may be a consideration in all patients.The following complications were reported as follows: plate group: there was a single case of nonunion after plate fixation that was treated with auto-iliac bone graft and revision plate fixation.2 superficial infection, 20 skin numbness, 2 skin irritation due to the plate and screws, 1 wound dehiscence and 1 reoperation.Ten group: 1 superficial infection, 2 skin numbness, 10 skin irritation proximal to the nail insertion site, 1 wound dehiscence, 12 clavicle shortening/ angulation.Shortening with angulation occurred in two ten cases; with undersized nails (2.0 mm) used in both instances these cases showed angulation of 25 and 35 degrees, respectively, 3 reoperation, 1 delayed union but no additional surgical treatment was done and the bone was united by 9-month follow-up and skin perforation in two patients required revision shortening of the ten.Two patients who underwent revision surgery to shorten the ten because of skin perforation and medial migration of ten.A case of an (b)(6) year-old male who underwent ten fixation had clavicle shortening and angulation at 2-weeks postoperatively.Union was achieved without further angulation at 24-weeks postoperatively.A case of a (b)(6)year-old male who underwent ten fixation had clavicle shortening and ten migrated to the proximal direction at 2 weeks after surgery.The nail penetrating the skin.6-weeks after nail cutting, bone union was achieved without further shortening.One of the two cases of skin perforation and migration.This report is for an unknown synthes 2.0 to 3.0 mm ten.It captures reported adverse events of skin irritation proximal to the nail insertion site, wound dehiscence, clavicle shortening/ angulation, reoperation, delayed union but no additional surgical treatment was done and the bone was united by 9-month and skin perforation in two patients required revision shortening of the ten.This is report 3 of 6 for (b)(4).

• Brand Name: UNK - ELASTIC NAILS: TITANIUM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 11856552
• MDR Text Key: 265973230
• Report Number: 8030965-2021-04081
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• 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: 04/23/2021
• 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