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

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

Patient Problem Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).510k: this report is for an unk - nails: 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 conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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

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: park bj, cho hm, and min wb (2015), a comparison of internal fixation and bipolar hemiarthroplasty for the treatment of reverse oblique intertrochanteric femoral fractures in elderly patients, hip pelvis, vol.27 (3), pages 152-163 (korea, south).The aim of this retrospective study is to compare the clinical and radiological results between internal fixation using the proximal femoral nail system and bipolar hemiarthroplasty (bha) in reverse oblique intertrochanteric hip fractures in elderly patients.Between january 2005 to july 2012, a total of 53 patients (16 male and 37 female) with an average age of 77.6 years (range 70-86 years) were included in the study.One group was treated with internal fixation using the proximal femoral nail system (31 cases), and the other group was treated with bha (22 cases).For the internal fixation group, proximal femoral nail (synthes, paoli, switzerland) was used in 9 cases and proximal femoral nail antirotation (synthes) in 11 cases.All the rest used devices from competitors.The average follow-up period was 42.84 months (range, 24-68 months).The following complications were reported: orif group: 5 patients died, 4 of which died within one year of their surgery and 1 died within three months.Orif group had blood loss of 142.3 ml (range, 70-260 ml).1 patient had artificial joint replacement due to early loss of reduction.1 patient required bha due to of periprosthetic fracture.3 patients showed a displacement >5 mm during the union of the lateral wall.1 patient had nonunion and underwent revision with bone grafting and additional plating, which achieved successful bony union.In a (b)(6) year-old male patient, a radiograph showed an insufficient reduction of the fracture fragment.The patient had an operation for removal of an internal fixative, as the patient complained of severe discomfort.An (b)(6) year-old female patient had nonunion of the fracture at 24-month follow-up and remains under long-term follow-up and is monitored regularly, as no significant pain was noted, and the patient declined to undergo reoperation in favor of using crutches.This report is for an unknown synthes pfn constructs and unknown synthes pfna constructs.This report is for (1) unk - nails: pfna.This report is 1 of 6 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in 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.

• Brand Name: UNK - CONSTRUCTS: PFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12342184
• MDR Text Key: 267265273
• Report Number: 8030965-2021-06825
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

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
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 09/21/2021
• Supplement Dates FDA Received: 09/23/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention