MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: A2FN; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Bone Fracture(s) (1870); Deformity/ Disfigurement (2360); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - constructs: a2fn/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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 (b)(6) as follows: this report is being filed after the review of the following journal article: choi, j.-y., sung, y.-b., yoo, j.-h., and chung, s.-j.(2014), factors affecting time to bony union of femoral subtrochanteric fractures treated with intramedullary devices, hip pelvis, vol.26 (2), pages 107-114 (korea, south).The aim of this retrospective study is to evaluate the factors affecting the bone union time and the occurrence of nonunion after intramedullary nailing of subtrochanteric femoral fractures in adults.Between february 2004 to march 2013, a total of 31 patients (22 male and 9 female) with an average age of 53.7 years (range, 18-78 years) underwent femoral intramedullary treatment.Proximal femoral nail (pfn), pfn antirotation (pfna), and a2fn (synthes, paoli, switzerland) were utilized for the surgery.Pfn, pfna, and a2fn were used for 13, 12, and 6 cases, respectively.The average follow-up period was 17.5 months (range, 13-50 months).The following complications were reported: 3 patients displayed nonunion.To treat the ununited fractures, autogenous bone grafts (2 cases) and intramedullary nailing exchange to plating and bone graft (1 case) were performed and achieved the bony union without additional complications.An unknown number of patients had an average degree of varus/valgus deformity was varus 0.45° (varus 6° -valgus 8°).An unknown number of patients had a postoperative displacement of fracture.A (b)(6) year-old female patient had nonunion seen on a radiograph at 9 months.A follow-up radiograph at 2 years shows bone union after revision surgery with locking compression plate fixation and autogenous iliac bone graft.This report is for an unknown synthes pfn constructs, unknown synthes pfna constructs, and unknown synthes a2fn constructs.A copy of the literature article is being submitted with this medwatch.This report is for (1) unk - constructs: a2fn.This report is 2 of 4 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: A2FN
• 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: 12183422
• MDR Text Key: 263447192
• Report Number: 8030965-2021-05838
• 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: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• 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: 06/18/2021
• 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