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 Non-union Bone Fracture (2369); Post Operative Wound Infection (2446); Physical Asymmetry (4573)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: yoon, y.C.Et al.(2022), intramedullary nailing of subtrochanteric fractures in elderly patients: comparative study of helical blade cephalomedullary nail versus reconstruction nail, injury,vol.53, pages 1477¿1483 (south korea).This study aimed to investigate whether cmn offers superior outcomes over rcn in the treatment of subtrochanteric fractures in elderly patients.Between 2013 and december 2018, 60 elderly patients (17 men and 43 women; mean age: 74.9 years) diagnosed with subtrochanteric fractures were treated with imn with helical blade cmn (cmn group: 30 patients) or rcn (rcn group: 30 patients) with at least 1 year of follow-up period.The cmn group used the proximal femoral nail anti-rotation (pfna; depuy synthes, solothurn, switzerland) with a helical blade system and the rcn group used the expert asian femoral nail (depuy synthes (b)(4)) with proxi- mal two recon locking screws.The following complications were reported as follows: cmn: (n=6) varus deformity; (n=11) anterior angulation difference; (n=6) merle d¿aubignéscore fair; (n=4) merle d¿aubignéscore poor.Rcn: (n=3) varus deformity; (n=7) anterior angulation difference; (n=3) merle d¿aubignéscore fair; (n=1) merle d¿aubignéscore poor.The article does not provide sufficient information to identify which device (pfna or expert) is associated with these adverse events: a 68-year-old female patient with subtrochanteric fracture of ao-ota classification 32a2 owing to a pedestrian traffic accident.Although fixation with cephalomedullary nailing was performed, the transition region of the nail where the thick proximal part tuns into the narrow distal part fits tightly into the intramedullary canal, and varus angulation was caused.Nonunion was observed in the fracture site 8 months after surgery.A 72-year-old female patient who had a pedestrian traffic accident presented a subtrochanteric fracture of ao-ota classification 32b2 and accompanying posteromedial bone defect due to a displaced wedge fragment.Fixation with reconstruction nail was performed.However, non-union in the fracture site was observed 6 months after surgery because of a large bone defect.Nail breakage occurred after 1 month, and varus angulation was observed.Bone union was not achieved in five cases because of mechanical problems (three cases) caused by varus and anterior angulation, unstable fixation caused by fracture site bone defect, (one case) and biological problems caused by aff (two cases).In these non-union cases, bone union was eventually achieved via plate augmentation with bone graft (three cases) and exchange nailing with a poller screw (one case), except in one case wherein the patient refused to undergo additional surgery.1 case had wound infection caused by a pressure and was treated via irrigation and debridement.This report is for an unk - constructs: pfna.This is report 1 of 4 for (b)(4).

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown device/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.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.

• Brand Name: UNK - CONSTRUCTS: PFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15111648
• MDR Text Key: 296662118
• Report Number: 8030965-2022-05233
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• 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: 06/28/2022
• 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