MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DIRECT MEASUR-DEVICE F/GUIDEWIRE Ø3.2; MISC ORTHO SURGICAL INSTR

Catalog Number 356.829

Device Problem Incorrect Measurement (1383)

Patient Problems Bone Fracture(s) (1870); Injury (2348); Blood Loss (2597); No Code Available (3191)

Event Date 06/03/2019

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.(b)(4).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 (b)(6) as follows: it was reported that on (b)(6) 2019, an open reduction internal fixation (orif) with japanese proximal femoral nail anti-rotation (pfna) - ii system was applied to surgery for femoral trochanteric fracture.During insertion of a pfna-ii blade, it penetrated the femoral head.The surgeon commented that during the measurement for the blade selection, the end of the protection sleeve was not in contact with the bone.Due to this, the measurement value became longer than the correct one.Thus, the length of the selected blade was longer than the proper length.Also, during the process of hammering, images were not taken continuously, thus, the surgeon did not check the images properly.During the same procedure, the surgeon tried to remove the blade.To do this, the surgeon connected an extraction screw with the blade yet, an extraction screw could not connected properly due to an unknown reason.As a result, the connection portion between an extraction screw and the blade broke while hammering.Thus, the blade could not be removed with an unknown removal device.Then, the blade was removed using another unknown removal device for broken locking compression plates.Then, the nail was removed and another nail was inserted.The event caused excessive bleeding, unnecessary broke of the bone, and risk of infection.The surgery was completed within a 30 minute delay.Patient outcome was unknown.Concomitant device reported: unknown pfna-ii nail (part #: unknown, lot #: unknown, quantity: 1) and impactor for pfna blade (part #: 356.823, lot #: unknown, quantity: 1); unknown hammer (part # unknown, lot# unknown.Quantity 1).This report is for one (1) direct measure-device f/guidewire ø3.2.This is report 4 of 4 for complaint (b)(4).

• Brand Name: DIRECT MEASUR-DEVICE F/GUIDEWIRE Ø3.2
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8741584
• MDR Text Key: 149482392
• Report Number: 8030965-2019-65836
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611819291348
• UDI-Public: (01)07611819291348
• 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: Physician
• Type of Report: Initial
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 356.829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention