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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/22/2015

Event Type  Injury  

Manufacturer Narrative

Report is for an unk - constructs: tibial 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.(b)(6).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: lim s.J., et al (2015) a forward-striking technique for reducing fracture gaps during intramedullary nailing: a technical note with clinical results, injury, int.J.Care injured volume 46, pages 2507¿2511 (korea, south) http://dx.Doi.Org/10.1016/j.Injury.2015.08.024.This study aims to describe a simple forward-striking technique for reducing the residual fracture gaps that may exist during cephalomedullary or intramedullary nailing.Between february 2013 and march 2014, the forward-striking technique was used during cephalomedullary or intramedullary nailing of 20 subtrochanteric or femoral shaft fractures and three tibial shaft fractures at two university teaching hospitals.Twenty-three patients were included in this study (13 men, 10 women; mean age at the time of index operation, 50 years; range, 18¿80 years).Five types of implant were used: six znn1 long cephalomedullary nails (zimmer, warsaw, in, usa), three a2fn1 reconstruction femoral nails (synthes, oberdorf, switzerland), eight a2fn1 femoral nails (synthes), three cfn1 femoral nail (synthes), and three etn1 tibial nail (synthes).Patients were followed up every 4¿6 weeks.The following complications were reported as follows: a case of a (b)(6) year-old woman who had atypical subtrochanteric fracture of the right femur the canal was overreamed by 1 mm.Had fracture gap after nail insertion.Reduction of the gap was done.Follow-up radiographs taken 12 months after nailing showed fracture healing with circumferential callus bridging.A case of an (b)(6) year-old male patient sustained an ao/ota 32-b distal femoral shaft fracture and underwent antegrade nailing.The canal was overreamed by 1 mm.Had fracture gap after nail insertion.Reduction of the gap was done.Uneventful fracture healing took place 4 months after nailing.A case of a (b)(6) year-old man with tibial shaft fracture intraoperative anteroposterior fluoroscopic imaging revealed small gaps along the medial and posterior fracture cortices.Gap was reduced with good contact along the posterior and medial cortices.Radiographs taken 3 months after nailing showed fracture healing with bridging callus.This report is for an unknown synthes a2fn1 reconstruction femoral nails, unknown synthes a2fn1 femoral nails,unknown synthes cfn1 femoral nail and unknown synthes etn1 tibial nail.This report is for one (1) unk - constructs: tibial nail.This is report 7 of 7 for complaint (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.H10 additional narrative: 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 captures a case of a 25-year-old man with tibial shaft fracture.Intraoperative anteroposterior fluoroscopic imaging revealed small gaps along the medial and posterior fracture cortices.Gap was reduced with good contact along the posterior and medial cortices.Radiographs taken 3 months after nailing showed fracture healing with bridging callus.

• Brand Name: UNK - CONSTRUCTS: TIBIAL NAIL
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11809038
• MDR Text Key: 265056382
• Report Number: 8030965-2021-03849
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR