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

Catalog Number 04.027.052S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Facility address not available for reporting.Device is not distributed in the united states, but is similar to device marketed in the usa.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 europe reports an event in (b)(6) as follows: it was reported patient underwent an open reduction internal fixation (orif) for a femoral trochanteric fracture, utilizing the proximal femoral nail antirotation (pfna) on (b)(6) 2018.After the pfna blade was inserted it was locked to the nail.However, the pfna impactor did not detach from the pfna blade and the blade was removed.Surgeon re-inserted the blade, fixed it in the usual manner, then detached the impactor.Surgery was completed successfully with a delay of approximately 30 minutes.No adverse consequence to the patient was reported.This report is for one (1) pfna blade.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

A device history record review was performed for the subject device: part no.: 04.027.052s , lot no.: l321466 , manufacturing location: (b)(4), release to warehouse date: 27.Feb.2017 , expiry date: 01.Feb.2027.No 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.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.

Manufacturer Narrative

A device history record review was performed for the subject device: part no.: 04.027.052s , lot no.: l321466 , manufacturing location: (b)(4), release to warehouse date: 27.Feb.2017 , expiry date: 01.Feb.2027.No 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.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): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7399794
• MDR Text Key: 104560371
• Report Number: 8030965-2018-52799
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819394216
• UDI-Public: (01)07611819394216(17)270201(10)L321466
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• 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: L321466
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1