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

Catalog Number UNK - CONSTRUCTS: PFNA

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

Patient Problems Hematoma (1884); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unknown - constructs: pfna.Unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.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.(b)(4).

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: schuetze k.Et al.(2019), impact of oral anticoagulation on proximal femur fractures treated within 24 h ¿ a retrospective chart review, injury, vol.50, pages, 2040-2044 (germany).The objective was to determine the effect of oral anticoagulation on patients with proximal femur fractures, which received a proximal femur nail antirotation (pfna) within 24 h after trauma.Between january 2013 nd december 2017, a total of 327 patients (104 males and 223 females) with a mean age of 80 years were treated with a proximal femoral nail antirotation with a perforated blade (fa.Depuy synthes) allowing augmentation with trauma cem v + cement (fa.Depuy synthes).The following complications were reported as follows: 26 patients died within the first postoperative year.74 patients needed a transfusion.21 patients need revision surgery because of postoperative hematoma.This report is for a proximal femoral nail antirotation with a perforated blade (fa.Depuy synthes) allowing augmentation with trauma cem v + cement (fa.Depuy synthes).These impacted products capture the reported revision, hematoma, transfusion.This report is for one (1) unk - constructs: pfna.This report is 1 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 9836418
• MDR Text Key: 194543083
• Report Number: 8030965-2020-01960
• 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,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - CONSTRUCTS: PFNA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2020
• 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