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 Necrosis (1971); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown 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. 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

Device report from synthes reports an event in china as follows: this report is being filed after the review of the following journal article: qiu s. , ma t. , liu h. , wan j. , (2020)timing of tranexamic acid administration in elderly patients with intertrochanteric fracture,international journal of clinical experimental medicine, volume 13(10), pages 7709-7717 (china). This study aims to explore the safety and effects of tranexamic acid administration at different time points on the blood loss in the perioperative period of elderly patients with intertrochanteric fracture treated with pfna. From january 2016 to april 2018, a total of 120 elderly patients with intertrochanteric fracture were admitted and were included in the study. Patients were divided into group a (ga, n
=
40) with 21 males, 19 females) age 68. 24±7. 25 year group b (gb, n
=
40) with 24 males, 16 females age 67. 43±5. 21 years and control group (cg, n
=
40) with 22 males and 18 females age 66. 94±5. 79 year. All patients were treated with pfna. The following complications were reported as follows: group a: 3 limb swelling, 2 intramuscular vein thrombosis, 2 incision fat liquefaction. Group b: 1 limb swelling, 2 intramuscular vein thrombosis, 1 incision fat liquefaction, control group: 3 limb swelling, 1 intramuscular vein thrombosis, 1 incision fat liquefaction. This report is for an unknown synthes proximal femoral nail antirotation (pfna). This is report 1 of 1 for (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: 11391980
• MDR Text Key: 240136765
• Report Number: 8030965-2021-01458
• 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: foreign,health professional,l

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• 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: 02/05/2021
• 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: 03/01/2021 Patient Sequence Number: 1