MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA-II Ø11 130° L240 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 473.806S

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Failure of Implant (1924); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.Patient gender not reported.Date of event: unknown.(b)(4).Unknown implant/explant date; no information as to if this was a revision surgery or intraoperative event reporter telephone number unknown.(b)(4).Device is not distributed in the united states, but is similar to device marketed in the usa.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Manufacturing review showed: manufacturing location: (b)(4).Manufacturing date: 20.Aug.2015 expiry date: 01.Aug.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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a proximal femoral nail antirotation (pfna) ii nail was broken at removal.The original implant date is unknown.It is also unknown if the nail was broken prior to a revision surgery or broke during a planned removal.No surgical delay or patient harm was reported.Patient status is unknown.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Patient exact weight reported as (b)(6).A manufacturing evaluation was completed: the product was returned in a packaging different from the original packaging.The laser marking was readable.Traces of use were visible and the nail is broken at citrus drill hole.A device history record review was performed for the affected lot, no abnormalities or deviations were detected, which could lead to the complaint failure.All dimensions relevant for the function of the product were measured, and fulfill the specifications.The raw material certificates were checked and it was found that all used raw material fulfilled the specifications.Based on this the complaint is rated as confirmed and not valid from the point of view of the manufacturing site.No manufacturing related issue was identified and it is not confirmed from the point of view of the manufacturing site.A product investigation was completed: 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.A blade, a bolt and an end cap were also received and it determined those parts are not responsible for the breakage of the nail.No product fault could be detected.(b)(6).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

It was clarified that the nail was broken post-operatively.The patient was working and felt severe pain.The patient went to the doctor and an x-ray reviewed a broken nail.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: therapy date unknown.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Concomitant devices reported: pfna-ii blade (part # 04.027.057s, lot # 9677747, qty 1).Locking bolt 4.9mm self tapping (part # 459.380, lot # 5935983, qty 1).Pfna-ii end caps (part # 473.170s, lot # 9708067, qty 1).

• Brand Name: PFNA-II Ø11 130° L240 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5982991
• MDR Text Key: 55800604
• Report Number: 9612488-2016-10403
• 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,Followup
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 473.806S
• Device Lot Number: 9605938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 70