MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: RAFN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: flanagan c.D., et al (2021) weight-bearing status may influence rates of radiographic healing following reamed, intramedullary fixation of diaphyseal femur fractures, orthopaedic trauma association xxxxx, pages 1-6 (usa).This retrospective case-control series aims to use a modified version of radiographic union scale for tibia (mrust) scores to investigate the effect of weight-bearing status on radiographic healing of diaphyseal femur fractures managed with intramedullary fixation.From january 1, 2010, to december 31, 2018, six-hundred ninety-five (n=695) skeletally mature patients with ota/ao type 32 injuries were identified.Patients were eligible for study inclusion if: the injury was managed with intramedullary fixation (retrograde or antegrade); postoperative weight-bearing status was non-weight bearing (nwb) or weight-bearing as tolerated (wbat).Overall, patients in this series were majority male (68.2%) and caucasian (62.3%) with mean age 32.7 years.The number of patients in each group was n=77.There were 52 males and 25 females in the nwb group age 33.0 years (13.4 sd ) while 53 males and 24 females in the weight-bearing as tolerated (wbat) age 32.4 years (15.3 sd ).For implant selection, all surgeons performed reamed, statically locked fixation utilizing the synthes retrograde/antegrade femoral nail (depuy synthes companies, warsaw, indiana).Mean radiographic follow-up was approximately 7.7months (231 vs 228days, p=.914).Reported complications: - two patients in the wbat group and 3 patients in the nwb group went on to have revision operations for fracture nonunion.The mean time to revision in the wbat group was 385days, compared with 372days in the nwb group.-delay radiographic healing: the number of patients who achieved radiographic follow-up to an mrust score of 12 was n=50 in the nwb group and n=53 in the wbat group.In the wbat group, the median time to mrust of 12 was 111days, compared with 162 days in the nwb group (p=.008).The number of patients who achieved radiographic follow-up to an mrust score of 13 was n=30 in the nwb group and n=40 in the wbat group.In the wbat group, the median time to mrust of 13 was 218days, compared with 278 days in the nwb group.The number of patients who achieved radiographic follow-up to an mrust score of 14 was n=29 in the nwb group and n=38 in the wbat group.In the wbat group, median time to mrust of 14 was 255days, compared with 320 days in the nwb group.This report involves one unk - constructs: rafn.

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.Additional narrative: this report is for an unknown constructs: rafn/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.

• Brand Name: UNK - CONSTRUCTS: RAFN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 15473698
• MDR Text Key: 300567267
• Report Number: 8030965-2022-07225
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• 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: 09/01/2022
• 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