MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAILS: UNIVERSAL NAIL; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Device report from synthes reports an event in israel as follows: this report is being filed after the review of the following journal article: davidson, a.Et al.(2022), initial definitive treatment of open femoral shaft fractures with retrograde nailing - is it safe? a retrospective analysis comparing antegrade to retrograde nailing, injury, vol.53, pages 1231-1236 (israel).The main goal of the study was to compare septic knee rates of patients treated with retrograde femoral nailing (rfn) as a primary treatment, with those treated with antegrade femoral nailing (afn) for high-grade open femoral fractures, including penetrating ballistic injuries.Our secondary goal was to evaluate both groups in terms of outcome, complication rates and reoperations.Between 2006 and 2016, 90 patients with open femur fractures were reviewed.Only 49 patients whose primary treatment was intramedullary nailing (imn), were included in the cohort.Thirty patients were treated with rfn (28 males and 2 females) and 19 with afn (17 males and 2 females).Implant used was a retrograde, usually 11.5mm nail (tri- gen, meta-tan, smith and nephew, memphis tn) for rfn and a universal ao nail (synthes, oberdorf, switzerland) for afn.Of the ninety cases, nineteen fractures were excluded as they were treated initially with ef.Within these nineteen cases, six were gustilo 3c injuries, where an urgent open vascular repair was conducted.Five of these patients were previously stabilized and fixed with ef at other hospitals before being transferred to our institution for definitive treatment.Three of the ef group died during their initial hospitalization, and three underwent above knee amputation due to ischemia and leg infection.The following complications were reported as follows: afn group: 2 patients who had deep surgical site infections within 4-6 weeks after nailing, were treated successfully by debridement and intravenous antibiotic therapy with retention of hardware.2 cases of nonunion which were treated by exchange nail technique or by addition of a plate.5 reoperations were hardware removal due to hardware irritation.2 cases had debridement.1 case had limb lengthening.1 case had malrotation correction.2 cases had nonunion surgery.This report involves one unk - nails: universal nail.This is report 1 of 1 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.This report is for an unknown nails: universal nail/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.(b)(4).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.

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.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 - NAILS: UNIVERSAL NAIL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 15463249
• MDR Text Key: 300370734
• Report Number: 8030965-2022-07201
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• 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: 09/21/2022
• 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