MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L90 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.053S

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 01/22/2018

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown; 510k: this report is for a blade - unknown lot.Device is not distributed in the united states, but is similar to device marketed in the usa.The device was removed from the patient intraoperatively.Complainant part has not been returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Patient experienced a surgical delay.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

The reported devices were used in surgery for femoral trochanteric fracture on (b)(6) 2018.After the implants were inserted and the incision site was closed, the surgeon found that the blade was inserted incorrectly through the nail under an x-ray image.The blade was replaced with a new one, and it took 20 minutes to finish the revision surgery.The surgeon commented that he did not properly assemble an aiming arm to the other instruments by mistake.There was an additional 60 minute delay for this patient¿s surgery.This complaint involves 3 parts.(b)(4).This report is for a blade.This complaint involves one (1) device.

Manufacturer Narrative

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

Concomitant medical products: pfna ii nail (472.103s, lot number unknown, quantity 1).

• Brand Name: PFNA-II BLADE L90 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7259530
• MDR Text Key: 99597813
• Report Number: 8030965-2018-50989
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819394223
• UDI-Public: (01)07611819394223(10)LOTUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.053S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention