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

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

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - constructs: pfna long/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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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 korea, south as follows: this report is being filed after the review of the following journal article: oh j-k, hwang j-h, sahu d (2010), nailing of intertrochanteric fractures: review on pitfalls and technical tips, journal of orthopedics, trauma and rehabilitation, volume 14, pages 3-7 (south korea).In this study, the authors describe the advantages and drawbacks of nailing over the dynamic hip screw for the fixation of hip fractures.The technical pitfalls of nailing and the tips to avoid failure of fixation in nailing have been discussed.Between march 1, 2007 and february 28, 2009, 101 intertrochanteric fractures with the unknown synthes proximal femoral nail anti-rotation were performed.There were who 6 patients died from other causes after discharge from the hospital while 7 patients were lost to follow-up.A total of 88 patients were followed up more than 6 months or to the point when fracture healing has occurred.Complications were reported: 1 patient had irritation and pain over the blade due to excessive sliding.The patient underwent revision surgery with the blade changed with a shorter one and the fracture healed uneventfully.1 patient had femoral head perforation due to migration of the blade just like the z-effect.The patient underwent revision surgery with the blade changed with a shorter one and the fracture healed uneventfully.Unknown patients had incidence of postoperative lateral wall fracture of a1 and a2 fractures.This report is for the unknown synthes proximal femoral nail anti-rotation.This report is for (1) unk - constructs: pfna long.This report is 1 of 3 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFNA LONG
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12344402
• MDR Text Key: 268219254
• Report Number: 8030965-2021-06898
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• 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: 07/21/2021
• 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