MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA-II BLADE L85 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.052S

Device Problems Crack (1135); Material Fragmentation (1261)

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

Event Date 07/17/2015

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Device was not implanted or explanted.Device is not distributed in the united states, but is similar to a device marketed in the us.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history review: manufacturing location: (b)(4) - manufacturing date: august 27, 2014 - expiry date: august 1, 2024.No non-conformance reports 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.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 from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a patient underwent a femoral subtrochanteric fracture procedure on (b)(6) 2015.During the procedure, the proximal femoral nail antirotation (pfna) blade interfered with the nail during insertion.The surgeon noted that the tip of the blade was nicked; therefore, a new 80mm blade was used instead.The surgery was extended for ten (10) minutes.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: a product investigation was completed: our investigation of the complained implant has shown that: the pfna-ii blade we have received back in locked condition and two of four edges (tip) are badly damage which indicates contact with the nail during insertion.Otherwise the article is in good condition.During a functional test, we found out that the implant is working as intended.We are not able to determine the exact reason for this reported problem, but it is likely that during the operation an application error may have taken place.To prevent such problems, it is necessary to operate according to the technique guide.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.

• Brand Name: PFNA-II BLADE L85 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: 4997742
• MDR Text Key: 22852459
• Report Number: 9612488-2015-10403
• 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: Followup
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.052S
• Device Lot Number: 9121736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1