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

Device Problem Device Slipped (1584)

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

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown pfna/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.(b)(4).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: wu, k.Et al.(2020), which implant is better for beginners to learn to treat geriatric intertrochanteric femur fractures: a randomised controlled trial of surgeons, metalwork, and patients, journal of orthopaedic translation, vol.21, pages 18-23 (china) the objective of this study was to compare whether the third-generation gamma nail-3 (gn-3) was better for junior surgeons to learn to treat geriatric intertrochanteric femur fractures than proximal femoral nail antirotation-ii (pfna-ii).From january 2011 to february 2017, a total of 350 patients were treated with a gn-3 fixation (n=169) and a pfna-ii (n=181).There were 78 males and 103 females for the pfna-ii group.The pfnaii nail used in the present study was available in various different sizes (9, 10, 11, or 12 mm in diameter and 170, 200, 240 mm long).The minimum follow-up was 12 months (mean, 27.2 months; range, 1242 months).The following complications were reported as follows: 2 patients died while in the hospital while 28 patients died within the year.During hospitalisation, 4 patients died.Three of them had acute pulmonary embolism or heart failure, and 1 had multiple organ failure.3 patients had nonunions/delayed unions.They underwent secondary surgeries to achieve union.2 patients had cutouts.These cases were managed by revision surgery (hip replacement).2 patients had implant breakage.One of these occurred with a fall at one year after surgery (breakage site at the opening for the blade).The characteristic was the sign of delayed union or nonunion with no evidence of loosening.2 patients had implant loosening.3 patients had periprosthetic fractures due to postoperative accidents and the others were caused by fall after bony union, all of whom were treated with short nails.1 patient had redisplacement.2 patients had tractus irritation.The visible mismatches on the radiograph were found in 98 cases (43 in the gn-3 group and 55 in the pfna-ii group) from a total of 350, and many patients had multiple mismatches.This report is for an unknown synthes pfna-ii this is report 4 of 4 for pc (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFNA-II
• 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: 11473736
• MDR Text Key: 242672350
• Report Number: 8030965-2021-01902
• 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
• Type of Report: Initial
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2021
• 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