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

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

Patient Problems Discomfort (2330); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).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: langenhan r, reimers n, probst a (2014), intramedullary stabilization of displaced midshaft clavicular fractures: does the fracture pattern (simple vs.Complex) influence the anatomic and functional result?, z orthop unfall, volume 152, page 588-595 (germany).The objective of this paper was to review our own patient cohort retrospectively in order to assess whether there are disadvantages in the anatomical or functional outcomes following treatment of multi-fragment displaced midshaft clavicular fractures (dmcf) (ota type 15b3) versus 2- (ota type 15b1 and 3-fragment fractures (ita type 15b2).Between january 2009 and december 2012, 37 patients (8 women, 29 men, mean age 35 years [16-60; sd 12.90]) who were treated for dmcf with open reduction and intramedullary nailing were included in the study.The patients were subdivided into 20 patients for group a (simple fractures: ota type 15b1 and 15b2) and 17 patients for group b (complex fractures: ota type 15b3).All patients were implanted with an unknown synthes titianium elastic nail.Complications were reported as follows: 1 patient had primary malposition of the intramedullary wire and underwent revision with plate osteosynthesis.A (b)(6) year-old male had a wound infection in the region of the surgical scar over the fracture after 4 weeks.The wound was debrided several times and a vacuum dressing applied with removal of the intramedullary wire after 6 weeks; the wound and fracture then healed free of infection and with very good functional scores.3 patients had an uncomfortable wire end at the medial entry site that had to be shortened within the first 3 weeks due to secondary telescoping.The further course of treatment of these 3 patients was also unremarkable with good healing of the fracture.These patients also had healing in shortening of clavicles with 5mm, 9mm, and 18mm.Unknown patients had shortening in healing of clavicles with a mean of 7.4mm.This report is for the unknown synthes titianium elastic nail.This report is for one (1) unk - elastic nails: titanium.This is report 3 of 3 for complaint (b)(4).

• Brand Name: UNK - ELASTIC NAILS: TITANIUM
• 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: 11785597
• MDR Text Key: 264557669
• Report Number: 8030965-2021-03646
• 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: 04/09/2021

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: 04/09/2021
• Initial Date FDA Received: 05/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention