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

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

Patient Problems Hemorrhage/Bleeding (1888); Physical Asymmetry (4573)

Event Type  Injury  

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.This report is for an unknown nails/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 italy as follows: this report is being filed after the review of the following journal article: ippolito, e.Et al.(2022), intramedullary nailing for lower limb polyostotic fibrous dysplasia in children: a long-term follow-up study, journal of pediatric orthopaedics, vol.42, number 5, pages e492¿e500 (italy).We report the long-term results in a cohort of patients in whom more than two-thirds of cases had intramedullary nailing (in) repeated during growth.Twenty-nine femurs and 14 tibias totally affected by fibrous dysplasia (fd) were treated by in 21 patients with polyostotic fd and mccune-albright syndrome.The patients had their first in at a mean age of 9.26 ±2.68 years (range: 4 to 14 y).In was repeated during growth in the younger patients, and all the patients underwent a mean of 2.13 femoral and 1.50 tibial in per limb.The last in was performed at a mean age of 16.42± 1.95 years (range: 11 to 19 y).Titanium elastic nails (ten: synthes) were used in femurs or in tibias or in both bones of 6 children aged 4 to 8 years, while adult humeral nails with a spiral blade (phn: synthes) or adult interlocking humeral nails (uhn: synthes) were used respectively in femurs and tibias of 4 children aged 6 to 9 years.In the remaining patients aged 9 years and over as well as in re-nailing of all our patients within this age range, an adult cervicodiaphyseal nail with a spiral blade (ufn: synthes) was used in femurs while adult interlocking nails (utn: synthes or tn: biomet), in tibias.The mean length of follow-up from the last in was 6.47 ±3.10 years (range: 3 to 14 y), and the mean age of the patients at follow-up was 22.85 ±3.53 years (range: 14 to 29 y) when lower limbs were fully grown in all but 1 patient.The following complications were reported as follows: grade iiib: 1 subtrochanteric femoral nonunion with a broken ufn, healed after nail replacement, and autologous bone grafting.1 femur refracture after tens, healed with a hip spica cast application.1 tibia refracture above an adult uhn 1 year after a double osteotomy, healed in plaster cast after nail removal.A 4-year-old female patient affected by mccune-albright syndrome causing a severe painful limp.One year after nailing with titanium elastic nails (tens), pain had disappeared.Five years later, the painful limp recurred after marked femoral growth with relative shortening of the tens that were removed and replaced with an adult cervicodiaphyseal nail.At the latest follow-up, 7 years after the third nail replacement, the patient was 21 years old and fully asymptomatic.The article does not provide sufficient information to identify which synthes device is associated with the adverse event.Grade iiib: 2 cases of acute postoperative loss of the neck-shaft angle correction after hip valgus osteotomy, successfully revised and stabilized with a postoperative spica cast application with the hip abducted.1 femoral case of massive intraoperative bleeding requiring blood transfusions, with marked increase of the surgical time.1 case of loosening of the cervical spiral blade caused by failure of the blade¿s locking bolt, successfully revised.Grade iiia: 2 femoral and 3 tibial cases of late loosening of the nail distal locking screw, that was removed.This report involves one unk - nails.This is report 5 of 6 for (b)(4).

• Brand Name: UNK - NAILS
• 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: 16253546
• MDR Text Key: 308260364
• Report Number: 8030965-2023-01066
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 01/27/2023
• 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: 01/09/2023
• 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