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

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

Patient Problems Post Operative Wound Infection (2446); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown pfna constructs/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.Zhao, k.Et al.(2020), treatment of unstable intertrochanteric fractures with proximal femoral nailing antirotation: traction table or double reverse traction repositor, journal of investigative surgery, vol.Xx, pages 1-7 (china).The objective of this retrospective study was to compare the efficacy of the double reverse traction repositor (drtr) and traction table with proximal femoral nailing antirotation (pfna) in the treatment of unstable intertrochanteric fractures.From january 2017 to june 2017, a total of 66 patients with unstable intertrichanteric fractures were treated with a pfna.They were divided into 2 groups.30 patients had the drtr.There were 6 males and 24 females.36 patients had the traction table.There were 15 males and 21 females.Follow-up was performed at 1, 3, 6, and 12 months, including radiographic evaluations for fracture healing and postoperative complications.The following complications were reported as follows.2 patients had died in follow-up.24 patients had deep vein thrombosis.5 patients had superficial wound infections.This report is for an unknown synthes pfna constructs.It captures the reported deep vein thrombosis and superficial wound infections.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: 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: 11426915
• MDR Text Key: 248799906
• Report Number: 8030965-2021-01687
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2021
• 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: 02/11/2021
• 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