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

Catalog Number 473.806S

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: device was used for treatment, not diagnosis.Patient date of birth and weight not reported.It is unknown when breakage occurred.(b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 completed.Manufacturing location: (b)(4), manufacturing date: october 7, 2014, expiry date: october 1, 2024.No non conformance records (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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in (b)(6) as follows: it was reported that patient had revision surgery on (b)(6) 2016 due to a post-operatively broken proximal femoral nail antirotation (pfna) nail.The nail was originally implanted on (b)(6) 2015.The hardware was removed and the patient was revised to a total hip replacement.Patient and surgery outcome is unknown.Delay of surgery time is also unknown.Concomitant part reported: pfna blade (part# 04.027.054s, lot# 9121747, qty 1).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: (b)(6).A manufacturing investigation was performed for the subject device (pfna-ii ø11 130° l240 tan, part 473.806s, lot 9179814).The product was returned in a packaging different from the original packaging.The laser marking was readable.Strong traces around the cone and the citrus hole of the shaft.Nail is broken on the position of the citrus hole.All dimensions relevant for the function of the product were measured, and fulfill the specifications.The dimension of the citrus hole could not be measured in reason of breakage, but the inspection sheet confirms a 100% dimension check during production.The raw material certificate was checked and it was found that the used raw material fulfilled the specifications.Based on this the complaint is confirmed but not valid from the point of view of the manufacturing site.No manufacturing related issue was identified and/or confirmed.Although the complaint condition was confirmed, a root cause could not be identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Clarification: there was no report of surgical delay or patient harm associated with the revision procedure on (b)(6) 2016.

Manufacturer Narrative

A product investigation was completed: for our investigation, we have received one broken nail, one pfna-blade and one intact screw.There is no indication/ affirmation, in the complaint description, that the pfna-blade and the screw have contributed to this complaint condition.Also there are no significant damages visible on both devices which could have contributed to the breakage of the nail.The microscopic view of the broken surface shows a homogenous surface what indicates material conformity.Unfortunately we are not able to determine the exact cause of this occurrence as no detailed clinical information is provided and not all involved parts were available.It is likely that a mechanical overload situation lead to the breakage.No product fault could be detected.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

Additional concomitant device: screw (part 459.340, lot 59321012, quantity 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6174781
• MDR Text Key: 62420748
• Report Number: 9612488-2016-10512
• 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: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• 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: 9179814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PFNA BLADE (PART# 04.027.054S, LOT# 9121747, QTY 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR