MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L85 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.052S

Device Problems Use of Device Problem (1670); Device-Device Incompatibility (2919); Migration (4003)

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

Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.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).The investigation could not be completed; no conclusion could be drawn, as no product was received.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 antirotation (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) pfna-ii blade.This is report 1 of 4 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

• Brand Name: PFNA-II BLADE L85 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8741359
• MDR Text Key: 149414816
• Report Number: 8030965-2019-65833
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819394216
• UDI-Public: (01)07611819394216
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• 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: 04.027.052S
• Device Lot Number: 4L05772
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2019
• Patient Sequence Number: 1
• Treatment: IMPACTOR F/PFNA BLADE; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - NAILS: PFNA-II; IMPACTOR F/PFNA BLADE; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - NAILS: PFNA-II
• Patient Outcome(s): Required Intervention