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

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

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown nail/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: mingo-robinet j, et al.(2021), fluoroscopic landmarks to recognize iatrogenic varus displacement (wedge effect) during cephalomedullary nailing of intertrochanteric fractures, injury, pages 1-7 (spain) the purpose of the current study is to determine the incidence of the ¿¿wedge effect¿¿ associated with usage of the intramedullary nailing for intertrochanteric femur fractures in our population and to define easy fluoroscopic landmarks to identify and prevent the wedge effect.Between january 2017 and july 2019, there were 369 extracapsular hip fractures operated in which 55 fractures with a varus malreduction were found on postoperative x-rays.Of these, 35 patients with intraoperative fluoroscopic images recorded were included in the study.A total of 31 were female, and the overall mean age was 86.6 (range 70-97) years.The included patients had residual varus malreduction of the hip operated in postoperative pelvis radiographs and with at least 1 anteroposterior and 1 axial intraoperative fluoroscopy images recorded to assess that perfect reduction in anteroposterior and axial views was obtained with close reduction at the very beginning of the procedure, and posteriorly, an iatrogenic varus malreduction was produced when inserting the nail (wedge effect).15 of these patients were treated with the unknown synthes 130 degrees proximal femoral nail antirotation, 8 with unknown synthes 125 degrees proximal femoral nail antirotation while the rest of the patients were treated with a competitor¿s device.Complications were reported as follows: a total of 55 fractures with a varus malreduction were found on postoperative x-rays.4 patients died in the first 3 months after surgery.Case 2, a (b)(6) year-old male implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail.Case 4, an (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail.Case 5, an (b)(6) year-old female implanted with pfna 125 degrees had an iatrogenic varus malreduction that was produced when inserting the nail.Case 6, a (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail.Case 8, a (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail.This patient died in the early postoperative period.Case 11, an (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail.Case 12, an (b)(6) year-old male implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail.This patient died in the early postoperative period.Case 13, a (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail.Case 18, a (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail.Case 19, a (b)(6) year-old female implanted with pfna 125 degrees had an iatrogenic varus malreduction that was produced when inserting the nail.Case 20, a (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail.Case 22, a (b)(6) year-old male implanted with pfna 125 degrees had an iatrogenic varus malreduction that was produced when inserting the nail.Case 23, an (b)(6) year-old female implanted with pfna 125 degrees had an iatrogenic varus malreduction that was produced when inserting the nail.Case 24, a (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail.Case 25, a (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail.Case 26, an (b)(6) year-old female implanted with pfna 125 degrees had an iatrogenic varus malreduction that was produced when inserting the nail.Case 28, an (b)(6) year-old female implanted with pfna 125 degrees had an iatrogenic varus malreduction that was produced when inserting the nail.Case 30, a (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail.Case 31, an (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail.Case 32, an (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail.Case 33, a (b)(6) year-old female implanted with pfna 125 degrees had an iatrogenic varus malreduction that was produced when inserting the nail.Case 34, a (b)(6) year-old female implanted with pfna 125 degrees had an iatrogenic varus malreduction that was produced when inserting the nail.Case 35, a (b)(6) year-old female implanted with pfna 130 degrees had an iatrogenic varus malreduction that was produced when inserting the nail.This report is for the unknown synthes 125 degrees proximal femoral nail antirotation nail.This is report 2 of 7 for (b)(4).Due to a limit of 20 impacted products per complaint, the rest of the reported events were captured in (b)(4).A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - NAILS: PFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12128936
• MDR Text Key: 271579197
• Report Number: 8030965-2021-05576
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2021
• 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
• Patient Age: 94 YR