MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: A2FN; NAIL, FIXATION, BONE

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

Device report from synthes reports an event in south korea as follows: this report is being filed after the review of the following journal article: kt hwang, md.Et al., (2023), outcomes of angular stable locking system in femoral diaphyseal fractures of elderly patients: a multicenter comparative study, clinics in orthopedic surgery vol 15 no.3, pages 349-357 (seoul korea).This multicenter comparative study aims to compare radiological outcomes of im nailing using asls screws to im nails with conventional interlocking screws in elderly patients with femoral shaft fractures.Between january 01, 2012 to january 01, 2017 a total of 129 patients (31 males and 98 females their mean age was 73.5 years (range, 65-87 years) were treated with a2fn and long-pfna.A2fn with two reconstruction screws was used in 110 patients (85.3%), and long-pfna was used in 19 patients (14.7%).Asls was used in 65 patients and asls non-use in 64 patients.The mean follow-up period was 23.5 months (range, 12-73 months).The following complications were reported as follows: delayed union occurred in 42 patients (32.6%).Nonunion was noted in 11 cases (8.5%).There were 13 failure cases: plate augmentation in 8 cases, exchange nailing in 2 cases, dynamization in 1 case, bone graft in 1 case and exchange nailing with plate augmentation in 1 case (fig.3).Fig.3.A 72-year-old female patient treated with antegrade femoral nails with two distal angular stable locking system screws.Nonunion was diagnosed at 9 months after operation.Immediate postoperative anteroposterior and lateral radiographs showing reoperation of exchange nailing with plate augmentation was performed.Follow-up radiographs at 6 months after reoperation show bone union was obtained.This report is for an unknown synthes a2fn.A copy of the literature article is being submitted with this medwatch.This is report 1 of 5 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D1, d2, d3, d4, g4-510k: this report is for an unknown constructs: a2fn/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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.

• Brand Name: UNK - CONSTRUCTS: A2FN
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18265474
• MDR Text Key: 329679465
• Report Number: 8030965-2023-15319
• Device Sequence Number: 1
• Product Code: JDS
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• 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: 11/13/2023
• 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