MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA-II BLADE L80 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.051S

Device Problem Bent (1059)

Patient Problem Sedation (2368)

Event Date 12/16/2015

Event Type  Injury  

Manufacturer Narrative

Device was not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.Manufacturing location: (b)(4).Manufacturing date: november 19, 2014.Expiry date: november 01, 2024.No non-conformance reports were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint,: the investigation could not be completed; no conclusion could be drawn, as no product was received.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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported there was a surgery for femoral trochanteric fracture was held on (b)(6) 2015.Both the nail and blade were applied during the surgery.After inserting the reported nail, the surgeon was only able to insert the guide wire forward or backward from the correct position; the position was confirmed with the image intensifier.Since the surgeon thought the issue might be due to loosen device, the reported nail was removed.The looseness was checked by performing the simulation; however, no issue was found.Then the surgeon inserted the nail and the guide wire into the femur; the surgeon tried to insert the reported blade from the incorrect position.Then it was found that the blade slightly interfered with the reported nail.Therefore, it was checked by using the image intensifier and it revealed that the blade had been beyond correct position forward.During removal it was found the tip of the blade was crushed.Furthermore, it was found that the hole for the blade in the reported nail was hollowed.Eventually, different sized blade and nail were replaced after treating soft tissue.And then, the surgical operation was completed.The surgical delay was sixty (60) minutes.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional information: the subject device has been received and is currently in the evaluation process.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Manufacturing investigation summary: the blade is stuck and shows deformations in the region of the tip of the blade.In addition, the blade showed several surface abrasions on different locations.Because in the complaint it was stated that there were problems inserting the blade into the citrus hole of the nail, all outer diameters of the blade were measured.The outer diameters of the subcomponents blade and end cap were conforming.The outer diameter of the subcomponent sleeve was found to be too large compared to the specifications.This fact leads to the observed complaint failure that the blade could not be completely introduced into the citrus hole of the nail.Based on this information, the complaint is rated as confirmed.As mentioned, the blade shows surface abrasions.In addition, it was found that the blade was stuck and could not be separated into its components.This indicates that, during the operation, strong forces might have been applied to the product, which could also lead to compression of the sleeve and to excursions in its diameter.No manufacturing related issues were identified and/or confirmed.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 L80 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5347714
• MDR Text Key: 35165581
• Report Number: 9612488-2016-10009
• 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: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.051S
• Device Lot Number: 9261243
• Other Device ID Number: GTIN: 07611819394209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention