MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CABLE/WIRE; WIRE, SURGICAL

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

Patient Problems Non-union Bone Fracture (2369); No Code Available (3191)

Event Date 10/29/2018

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown wire/ 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.(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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: shin, w.C.Et al (2019), technical note and surgical outcomes of percutaneous cable fixation in subtrochanteric fracture: a review of 51 consecutive cases over 4 years in two institutions, injury, vol.50 (2), pages 409-414, https://www.Injuryjournal.Com/article/s0020-1383 (18)30632-6/ abstract, (south korea).The aim of this retrospective observational study is to introduce their surgical technique and report surgical outcomes for percutaneous cable fixation in the treatment of subtrochanteric femoral fractures.Between may 2013 to april 2017, 51 patients (34 male and 17 female) with a mean age of 57.8 years (range, 17-86) were treated with closed intramedullary nailing and percutaneous cable fixation.Surgery was performed using expert antegrade femoral nail (a2fns) with two recon screws (depuy synthes, oberdorf, switzerland) in 3 patients, long proximal femoral nail anti-rotation (pfna; depuy synthes, oberdorf, switzerland) in 44 patients, and a competitor's device in 4 patients, based on the fracture geometry and canal width.Single cerclage cables were used in 29 patients (56.8%), with 2 cables used in 20 patients (39.2%), and 3 cables in 2 patients (3.9%).Average follow-up period was 18.8 months (range 12 - 36).The following complications were reported as follows: 50 out of 51 patients achieved bone union.This report is for an unknown synthes wire.It captures the reported event of nonunion.This is report 3 of 3 for complaint (b)(4).

• Brand Name: UNK - CABLE/WIRE
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9801321
• MDR Text Key: 193378166
• Report Number: 8030965-2020-01695
• Device Sequence Number: 1
• Product Code: LRN
• 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: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• 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: 02/12/2020
• 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