MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA BLADE PERF L100 TAN; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.027.035S

Device Problem Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Date of event is unknown.Udi: (b)(4) lot number unknown device is not implanted/explanted.Reporter phone number: (b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number, the device history record review could not be requested.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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 europe reports an event in (b)(6) as follows: it was reported that during a surgery it was not possible to remove the proximal femoral nail antirotation (pfna) blade from the impactor for the pfna blade.The surgery was prolonged for about five (5) minutes.There was no patient harm.This report is for one (1) pfna blade.This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

A product development investigation was performed for the subject device.The present articles (impactor f/pfna blade and pfna blade perf l100 tan ) were checked.Manufacturing and inspection records indicated no problem with the lot in question.The investigation has shown that the pfna blade is jammed on the impactor.Further investigation has shown that on the surface of the pfna blade are visible strong marks.At the head end of the impactor there are strong impact marks visible, the welding between handle and shaft is broken and also a part of blue handle is blow out.Based on these findings we have to assume that excessive strokes on the impactor have caused the breakage of the welding seam and the jammed pfna blade.We can not remove the pfna blade from the impactor.We have to assume that there were a handling fault.The pfna blade were not properly screwed on the impactor as a result of excessive hammer blows jammed the connection between blade and impactor.Report was initially submitted on october 27, 2017 but the fda site was down.Advised by fda on november 06, 2017 to resubmit medwatch.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFNA BLADE PERF L100 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: 6810118
• MDR Text Key: 83626953
• Report Number: 9612488-2017-10424
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.035S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/22/2017
• Supplement Dates Manufacturer Received: 10/27/2017
• Supplement Dates FDA Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1