MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA-II BLADE L105 TAN; APPLIANCE,FIXATION,NAIL/BLADE PLATE COMBO, SINGLE COMPONENT

Catalog Number 04.027.056S

Device Problem Sticking (1597)

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

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient id, dob, and weight not provided for reporting.Other udi: (b)(4).Device is not distributed in the united states, but is similar to device marketed in the usa device malfunctioned intra-operatively and was not implanted / explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Reporters phone number: (b)(6).510k# unknown: device history records review was conducted.The report indicates that the: 04.027.056s / 9568727.Manufacturing location: (b)(4).Manufacturing date: 15.Jul.2015 expiry date: 01.Jul.2025.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 on an event in (b)(6) as follows: the reported device was used in surgery for the proximal femoral fracture.As instructed, the nail was inserted, and then the blade in question was selected.The selected blade in question was installed to the inserter.After installation, the surgeon made sure with a scrub nurse that the tip of the blade would rotate properly.As instructed, the blade was inserted to the nail.The blade insertion was being checked by the imaging study.However, it was found that the surgeon had a difficulty in inserting the blade from the blade bit part.The surgeon was told to remove the blade for a moment.The surgeon checked whether the blade bit would rotate.At this point, the blade did no longer rotate.To search for the cause of this blade problem, the blade was removed from/installed to the inserter several times, the problem did not improve.In a meanwhile, a risk of interference in the blade with the nail was explained by our sales rep to the surgeon.By the reamer 90mm for the bone head, the surgeon checked whether there was any interference (the bone head reamer was not interfered.) another blade in a same size from the other implant set was used to finish the procedure.The surgery was extended for 10 minutes.No adverse consequence to the patient was reported.This complaint involves 1 part.Concomitant devices: 1x unk nail, 1x unk insertor, 1x unk reamer 90mm.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Date returned to manufacturer subject device has been received and a product development investigation was completed.1x article 04.027.056s with lot 9568727 / pfna-ii blade l105 tan was returned.As received condition: blade was received in a locked condition.Traces of use on recess, front section and shaft are visible where the anodized green color is partially shaved off.A functional check was performed together with impactor for pfna blade and blade could be attached to the impactor as intended plus the tip section did rotate freely.Detaching of blade off impactor was possible as well without any problem and blade did lock afterwards as intended.No further additional investigations such as measurements were taken as no findings were found by dhr-review.Review of the device history record showed that this blade was manufactured july 15 with a quantity of (b)(4) pieces.No manufacturing related deviation was noted.The exact root cause for this complained issue could not be detected during investigation.We do refer on to the surgical technique for pfna-ii proximal femoral nail antirotation in order avoiding such problems: 036.000.035 complained issue (blade problem) could not be confirmed based on the provided functional check.Further the detected traces of use are a sign of normal use and review of dhr-did not show any relation to any manufacturing related failure.Discarded as per procedures.Device 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 L105 TAN
• Type of Device: APPLIANCE,FIXATION,NAIL/BLADE PLATE COMBO, SINGLE COMPONENT
• 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: 6648672
• MDR Text Key: 77884552
• Report Number: 9612488-2017-10272
• Device Sequence Number: 1
• Product Code: KTW
• 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: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.056S
• Device Lot Number: 9568727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1