MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA-II BLADE L95 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.054S

Device Problems Fitting Problem (2183); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/06/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information is not available for reporting.Additional device product code is hwc.Other number¿udi: (b)(4).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.Reporter¿s phone number is (b)(6).510(k): device is not distributed in the united states, but is similar to device marketed in the usa.The subject device is currently undergoing investigation; the results are pending completion.A device history record review was performed for the subject device lot.Manufacturing location: (b)(4).Date of manufacture: aug 4, 2016.Expiration date: jul 1, 2026.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 synthes europe reported an event in (b)(6) as follows: it was reported that during surgery on (b)(6) 2017, the proximal femoral nail antirotation (pfna) blade locking mechanism failed during insertion.The blade couldn¿t be hammered into the nail and got stuck.The complainant blade was removed and a new blade was placed without incident.There was a surgical delay of approximately 15 minutes due to the reported event.The surgery was successfully completed without patient harm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product development investigation was performed for the subject device pfna-ii blade (b)(4)).The subject device was returned with the complaint condition stating:visual investigation shows a lot of damages at the surface of the complained part which are result of strong mechanical impact during insertion.The blade came in strong contact with other metallic part during use.We reasonably conclude that the blade was not properly aligned with the nail during insertion; therefore, the blade jammed in the hole and could not be inserted as intended.The manufacturing evaluation concluded there were no issues.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 L95 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6285980
• MDR Text Key: 66050344
• Report Number: 9612488-2017-10040
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.054S
• Device Lot Number: L080943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/04/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1