MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: AFN; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problem Malunion of Bone (4529)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown constructs: afn/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.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

Device report from synthes reports an event in taiwan as follows: this report is being filed after the review of the following journal article: yang, t.C.Et al (2021), ¿ratio of fracture site diameter to isthmus femoral canal diameter¿as a predictor of complication following treatment of infra-isthmal femoral shaft fracture with antegrade intramedullary nailing, injury, vol.Xx (xx), pages 1-6 (taiwan).The aim of this retrospective study is to analyse the fi ratio as a predictive factor for occurrence of complication, including non-union, mal-alignment, or fixation failure, following treatment of infra-isthmal femoral shaft fractures using antegrade im nailing.Between january 2008 to december 2018, a total 65 patients (41 male and 24 female) with a mean age of 47.1±21.9 (range, 20 to 91) years underwent closed reduction and internal fixation with antegrade im nailing.Surgery was performed using expert antegrade femoral nail (depuy synthes, oberdorf, switzerland), simplified universal nail (depuy synthes, oberdorf, switzerland), and competitor device.All patient had a minimum of 1-year follow-up.The mean follow-up period was unknown.The following complications were reported as follows: a 51-year-old male patient showed at 6-month radiograph with progressive angulation.7 patients had a malalignment.4 patients had a progressive loss of reduction.3 patients had nonunion and underwent reoperation.4 patients had a fixation failure and underwent reoperation.This report is for an unknown constructs: afn.This is report 2 of 4 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: AFN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 11436162
• MDR Text Key: 247504729
• Report Number: 8030965-2021-01708
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 02/11/2021

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: 02/11/2021
• Initial Date FDA Received: 03/08/2021
• 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