MAUDE Adverse Event Report: SYNTHES GMBH UNK - ELASTIC NAILS: TITANIUM; PIN, FIXATION, SMOOTH

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

Patient Problems Bone Fracture(s) (1870); Pain (1994); Post Operative Wound Infection (2446); 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 elastic nails: titanium/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

This report is being filed after the review of the following journal article ouillette, r., bastrom, t., newton, p.And pennock, a.(2022) elastic intramedullary nails in the treatment of pediatric length unstable femur fractures, journal of pediatric orthopaedics, vol.42 (04) pages 201-208 (usa).The aim of this retrospective study is to evaluate whether elastic intramedullary nails (eins) are an appropriate treatment option for length unstable diaphyseal femur fractures; also to evaluate risk factors for surgical complication when managing unstable femur fractures with ein and to determine the efficacy and role of adjunctive casting in the management of femur fractures undergoing ein.Between january 1998 to february 2020, 136 patients were found to have diaphyseal femur fractures treated with flexible intramedullary nails at our institution during the study period.In total, 50 (9 female and 41 male) of the fractures were classified as length stable, whereas 37 (7 female and 30 male) were classified as unstable.Of the unstable fractures, 24 (64.8%) were long oblique/spiral and 13 (35.2%) were comminuted.The majority of the nails (79/87 or 91%) were electively removed at our institution.Two titanium elastic intramedullary nails from a single vendor were used in all cases (synthes, paoli, pa).The majority of the nails (79/87 or 91%) were electively removed at our institution.The mean time to ein removal was 10.5 months (range 2 to 28).All patients achieved radiographic healing with a mean latest radiologic follow-up of 12.7 months (range 3 to 70).The following complications were reported as follows: a 10-year-old boy with a length stable left femur fracture after a motor vehicle accident.Patient was treated with flexible nails and knee immobilizer, and he went on to heal with 12 degrees of varus.At final follow-up, the patient was asymptomatic, had required no further treatment, and had returned to full activities.An 8-year-old boy with a length unstable left femur fracture after a fall from a skateboard.Patient was treated with flexible nails and a knee immobilizer.In the early postoperative period his fracture shortened more than a cm requiring revision surgery to trim the ends of the nails that were symptomatic.At final follow-up, his long-leg films demonstrated an 8mm leg length discrepancy with the injured side being shorter that was asymptomatic and required no further treatment.A 6-year-old boy with a length stable left femur fracture after a pedestrian versus auto accident.The patient was treated with flexible nails and a knee immobilizer.Patient did well initially but returned to clinic years later complaining of a leg length discrepancy.His left femur overgrew by > 2 cm and he was treated with epiphysiodesis.A residual angular deformity >10 degrees was noted in 9/87 (10.3%) fractures and none of the angular deformities required further intervention or change in postoperative management.(fig.1) clinically significant leg length discrepancy was observed in 13/87 (15%) of our patients with a positive galeazzi test, prompting us to obtain long leg alignment films.However, a measurable leg length discrepancy >1 cm was seen in only 8 of these individuals with 3 patients (2 in the length unstable group and 1 in the length stable group).3 patients (2 in the length unstable group and 1 in the length stable group), only 1 patient in the length unstable group had a residual leg length discrepancy measuring 8mm (fig.2).Fracture overgrowth >1 cm was noted in 4 patients all of whom were in the length stable group (8%).Of these patients, 2 had an injured extremity that was 10 to 15mm longer than the uninjured extremity and were monitored clinically, whereas the other 2 patients had overgrowth >2 cm and additional surgery was recommended for both of these patients (fig.3).8 patients had complications: (n=1) painful hardware with premature removal of implants, (n=1) superficial infection following removal of nails, treated with antibiotics, (n=2) painful hardware with premature removal of implants, (n=1) malrotation confirmed with ct with no intervention required, (n=2) overgrowth of affected limb >2 cm, requiring epiphysiodesis, (n=1) fracture shortening with prominent nails requiring trimming of nails before definitive removal.This report involves one unk - elastic nails: titanium.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - ELASTIC NAILS: TITANIUM
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 16253742
• MDR Text Key: 308259896
• Report Number: 8030965-2023-01071
• Device Sequence Number: 1
• Product Code: HTY
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/09/2023
• Initial Date FDA Received: 01/27/2023
• 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