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

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

Patient Problem Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

Pma/510k: this report is for an unknown pfn construct/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: jafarullah, z. M. Et al. (2020), morphology specific lateral wall reconstruction techniques using cerclage wires in unstable trochanteric fractures, indian journal of orthopaedics, vol. 54(2), pages s328-s335 (india). The goal of this study is to present a simple morphology specific reconstruction techniques for lateral wall fractures (lwf) using cerclage wire around proximal femoral nails along with the review of the literature about the other surgical options available for lateral wall reconstruction. Between january 2016 to december 2018, a toal of 49 patients with intertrochanteric femur fracture patients with lwf underwent proximal femoral nailing and lateral wall reconstruction. There were 30 male and 19 female patients. The mean age of the population was 66 years (36¿91 years). The implant used was a pfn. All patients except one underwent long pfn fixation. One patient with a distal femur locking compression plate in situ underwent short pfn fixation. The mean follow-up period was 13 months (10¿36 months). The following complications were reported as follows: 1 patient had avascular necrosis of the femoral head. 4 patients had superficial infection. 1 patient had varus collapse with non-union and implant failure. 1 patient had screws back out. 1 patient had distal screw breakage. This report is for an unknown synthes pfn. It captures the reported adverse events of avascular necrosis of the femoral head. A copy of the literature article is being submitted with this medwatch. This is report 1 of 4 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFN
• 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: 11408087
• MDR Text Key: 244761156
• Report Number: 8030965-2021-01586
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 03/03/2021 Patient Sequence Number: 1