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 Weakness (2145); Hypoesthesia (2352); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - elastic nails/unknown lot.Part and lot numbers are unknown; udi number is unknown.Implantation date 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 product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 united kingdom reports an event as follows: this report is being filed after the review of the following journal article: borton, z.M., weil, s., ibrahim, e.F., and clark, c.(2019), severe neurovascular compromise associated with plastic deformation of ulna elastic nail following forearm refracture, coreus, vol.11, pages 1-7 (united kingdom).This study presents a case report of a (b)(6) year old caucasian male patient who sustained diaphyseal fractures of the left radius and ulna.The fractures were managed surgically with closed reduction and 3.0 mm intramedullary elastic nailing (esin) of the ulna and open reduction and internal fixation (orif) of the radius with a 3.5 mm dynamic compression plate (dcp).One week prior to metalwork removal the patient tripped and fell onto his outstretched left hand.He presented with severe clinical deformity of the forearm and severe distal neurovascular deficit.The hand was pale with an absent radial pulse, prolonged capillary refill time (crt) and no digital signal on pulse oximetry.Furthermore, both sensory numbness and motor weakness in the distributions of both median and ulna nerves were noted.Post reduction radiographs revealed persistent angular deformity of sixty degrees.Re-fracture of the ulna with plastic deformation of the flexible nail was again noted, as was a periprosthetic fracture at the distal margin of the radial plate.The im nail- though deformed- was intact allowing successful removal via the routine method from the proximal ulna entry point; however, satisfactory reduction could still not be gained.The radius was approached through the previous volar approach and re-plated, ensuring use of a longer 3.5 mm dcp to account for the previous screw holes.The ulna was then approached directly and internal fixation with a second 3.5 mm dcp performed.Postoperative recovery was untoward, and the patient was discharged after overnight observation.At two-month follow-up, the radiographs revealed fracture union.This report is for an unknown synthes esin and dcp.This report is for (1) unk - elastic nails.This is report 1 of 3 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10856129
• MDR Text Key: 218505535
• Report Number: 8030965-2020-09001
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• 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: 10/29/2020
• 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
• Patient Age: 13 YR