MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ROD, FIXATION, INTRAMEDULLARY

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.Date of event is unknown.This report is for an unknown proximal femur nail anti-rotation-ii (pfna-ii) blade.Twenty-three (23) patients experienced cut out postoperatively.Part and lot numbers are unknown.Without the specific part and lot number, the udi is not available.Implant date, explant date: unknown.Complainant device is not expected to be returned for manufacturer review/investigation.Reporter phone number is not provided for reporting.Device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.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.(b)(4).

Event Description

This report is being filed after the subsequent review of the following literature article yam m., chawla a., kwek e.(2017) rewriting the tip apex distance for the proximal femoral nail anti-rotation.Injury j.Care injured 48, pp.1843-1847.(b)(6).The purpose of the study was to evaluate the factors that predispose to cut out of the pfna implant and to provide a guide for surgical fixation.The study included 340 patients (103 males & 237 females) with a mean age of 82, who all underwent pfna-ii insertion between the years of 2011 and 2013.The patients were separated in three groups based on their ao classification (31a1, 31a2, 31a3); however, despite their classification every patient was implanted with the proximal femur nail anti-rotation (pfna-ii) (synthes (b)(4)).A total of 23 patients were discovered to have cut out post-operatively.This report is for an unknown pfna-ii blade.Twenty-three (23) patients experienced cut out postoperatively.This is report 1 of 1 for (b)(4).

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7338275
• MDR Text Key: 102440327
• Report Number: 8030965-2018-52061
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention