MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L90 TAN; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 04.027.053S

Device Problem Device Difficult to Maintain (3134)

Patient Problem No Patient Involvement (2645)

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.510k device is not distributed in the united states, but is similar to device marketed in the usa.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that the patient underwent a proximal femur nailing procedure using the proximal femoral nail antirotation (pfna-ii) for a trochanteric fracture on (b)(6) 2019.During surgery, the pfna-ii blade did not work properly and failed interlocking options.There was a surgical delay of 45 minutes.The procedure was completed successfully using a different pfna-ii implant.Patient outcome is unknown.Concomitant device: unknown pfna-ii nail (part# unknown, lot# unknown, quantity# 1).This complaint involves one (1) device.This report is 1 of 1 for (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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Visual inspection: upon visual inspection of the complaint device it can be seen that we have received the article in a slightly open condition.Furthermore, the received device shows dents and scratches all over the surface of the part.Functional test: during investigation a functional test was performed, the blade passed the functional test.In addition, in fully open condition the part shows some post-manufacturing damage, based on this damage the function is a bit sluggish dimensional inspection: as the blade is fully functional, the complaint is unconfirmed and no further investigation will be done, as material and dimension evaluation.Furthermore, the reported device was assembled according to drawing, and all parts went through a functional test, before they had left the production.Summary: there is no particularize information what's happened to this article by customer, unfortunately we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation an application error may have taken place.No product fault could be detected.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot part: 04.027.053s lot: l708136 manuf.Site: bettlach release to warehouse: 03.January 2018 expiry date: 01.December 2027 a manufacturing record evaluation was performed for the finished device lot 708136, and no non-conformances were identified.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 L90 TAN
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8302532
• MDR Text Key: 134969577
• Report Number: 8030965-2019-60612
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819394223
• UDI-Public: (01)07611819394223
• 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,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.053S
• Device Lot Number: L708136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Date Manufacturer Received: 02/20/2019
• Patient Sequence Number: 1