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); Impaired Healing (2378); Malunion of Bone (4529); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unk - constructs: pfna/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 product was received; no conclusion could be drawn at the time of filing this report.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 (b)(6) as follows: this report is being filed after the review of the following journal article: freigang, v.Et al.(2019), risk factor analysis for delayed union after subtrochanteric femur fracture: quality of reduction and valgization are the key to success, bmc musculoskeletal disorders, vol.20, number 391, pages 1-8 (germany).The purpose of this study was to evaluate potential risk factors for delayed fracture healing after subtrochanteric femur fractures (sff) a total of 61 patients with subtrochanteric femur fractures were treated with intramedullary nailing.The mean age of the patients was 58.8 years (±18.4).There were 39 males and 22 females.Implants used were pfn-a (synthes inc., zuchwil, switzerland) for 51 patients, afn for 2 patients and a gamma nail (stryker inc., kalamazoo, usa) for 3 patients.Minimum follow up was 12 months postoperatively.The article did not specify which of the devices were being used to capture the following complications: 9 patients died within the first 3 months after surgery.4 patients had a concomitant compartment syndrome of the thigh treated by fasciotomy and secondary closure within 10 days at the latest.6 patients showed prolonged wound healing with secretion longer than day 5, none of them needed revision for surgical site infection.2 patients were revised for malreduction concerning rotation within the first week after initial surgery.3 patients sustained mechanical complications: 2 patients had breakage of the implant 4 months and 6 months after initial treatment.1 patient had adjacent fracture 6 weeks after.32 patients were rated as delayed fracture healing.4 patients required revision for symptomatic nonunion of the sff.9 patients required revisions.This report is for an unknown synthes pfna.This report is for (1) unk - constructs: pfna.This is report 1 of 3 (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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11367289
• MDR Text Key: 242468272
• Report Number: 8030965-2021-01269
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/23/2021
• 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