MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA Ø12 LONG LE 125° L380 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.249S

Device Problem Break (1069)

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

Event Type  Injury  

Manufacturer Narrative

Patient id, date of birth and weight are not available for reporting.(b)(4).(b)(6).(b)(4).The 510(k): device is not distributed in the united states, but is similar to device marketed in the usa.Device records review was completed for part # 04.027.249s, lot # 9943331.Manufacturing site: (b)(4), manufacturing date: may 18, 2016, expiry date: may 01, 2026.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received and the product evaluation is in progress.No conclusion can be drawn.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.

Event Description

Device report for synthes europe reports an event in (b)(6) as follow: it was reported that second (2nd) revision surgery was scheduled to be performed on (b)(6) 2016, due to breakage of proximal femoral nail-antirotation (pfna) nail.The patient initially had the pfna system implanted on an unknown date approximately two (2) months prior to the first (1st) revision surgery to treat a sub trochanteric fracture.Two months (date also unknown) later patient has presented with the nail broken at the point where the blade crosses through.The surgeon acknowledged that there was quite a large bone void which was left.During the revision surgery on (b)(6) 2016, the original nail was removed and the patient was revised with another pfna nail.First revision surgery is capture under (b)(4).This report is for one (1) pfna nail.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: an investigation summary was performed.The investigation of the complaint articles has shown that: we have forwarded the received nail (04.027.249s / 9943331) to the responsible manufacturing site for investigation, here is the statement: upon visual inspection, the product was returned in a packaging different from the original packaging.The laser marking was readable.The nail was cross broken in the position of the citrus hole.Traces of use were visible around the citrus hole.Slightly traces of use were visible on the other part of the nail.A device history record (dhr) review was performed for the affected lot, (b)(4) parts were delivered to the warehouse, no abnormalities or deviations were detected, which could lead to the complaint failure.The article was manufactured in may 2016.No ncrs were marked in the dhr during production.Moreover a review of our complaints data base shows, that there are no other complaints for this issue from this article and lot number.The outer diameter which is relevant for the function of the product was measured, and fulfills the specifications.Citrus hole could not be measured in reason of breakage.The according inspection sheet shows a 100% approval of the dimension of the citrus hole.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, but not valid from the point of view of the manufacturing site.No manufacturing related issue was identified and/or confirmed.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.Furthermore, we have also received two intact parts (1x blade 04.027.035s / l021208 and 1x screw 459.500 / 5935376): as those parts are not responsible for the breakage of the nail, no further investigation will be done.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 Ø12 LONG LE 125° L380 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: 6099105
• MDR Text Key: 59745268
• Report Number: 9612488-2016-10459
• 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: 10/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 04.027.249S
• Device Lot Number: 9943331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2016
• Initial Date FDA Received: 11/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR