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 Malunion of Bone (4529); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: barnett s.A., et al,(2021)/intraoperative burden of flexible intramedullary nailing and spica casting for femur fractures in young children, j pediatr orthop vol 41, number 7, 499¿505 (usa).This retrospective study aims to compare the intraoperative burden, defined as anesthetic exposure, fluoroscopic duration, and radiation load, between spica and flexible intramedullary nails (fins) treatment of femoral shaft fractures in young children.Between 2012 to 2017, a total of 143 patients ages 2 to 6 years (mean age 3.8+-1.4y) met inclusion criteria.The spica group contained 91 patients; fin contained 52 patients.In all cases, 2 flexible titanium were used (synthes titanium elastic nail system, west chester, pa).The following complications were reported as follows: spica group: 17 patients had skin irritation.4 patients had cast wedging.5 patients had loss of reduction.Fin group: 9 patients had symptomatic hardware.3 patients had loss of reduction.This report is for an unknown synthes titanium elastic nailing system (tens).A copy of the literature article is being submitted with this medwatch.This report involves one unk - elastic nails: titanium.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.Additional narrative: 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.

• 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: 16264449
• MDR Text Key: 308377139
• Report Number: 8030965-2023-01127
• 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: 01/10/2023
• Initial Date FDA Received: 01/30/2023
• 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