MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L95 TAN; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.027.054S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 03/12/2018

Event Type  Injury  

Manufacturer Narrative

Patient information not available for reporting.Device malfunctioned intra-operatively and was not implanted / explanted.Date returned to manufacturer device is not distributed in the united states, but is similar to device marketed in the usa.(b)(4) - no code available used to capture change in surgical plan.Surgeon used a different size blade than originally planned.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 on (b)(6) 2018.Implanted during the procedure was a proximal femoral nail antirotation (pfna) nail, pfna blade, and unknown quantity of locking screws and end caps.During the procedure, after insertion of the pfna blade, surgeon attempted to lock the blade but was not successful.Surgeon then used a different pfna blade of a different size and was able to successfully lock it to the nail.Surgery was completed successfully with no adverse consequence to the patient.Concomitant devices reported: pfna nail (part number unknown, lot number unknown, quantity 1), locking screw (part number unknown, lot number unknown, quantity unknown), end cap (part number unknown, lot number unknown, quantity unknown).This report is for one (1) pfna blade.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: dhr review was completed.Part: 04.027.054s, lot: l360623, and manufacturing site: (b)(4).Release to warehouse date: 30.Mar.2017.Expiry date: 01.Mar.2027.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Customer quality conducted an investigation of the returned device.The pfn, pfna, pfna-ii, tfn design and clinical risk management (dcrm) document was reviewed and found to adequately address the harm of this complaint condition.As received condition: the complained pfna-ii blade shows some slightly signs of contact with the nail which are from insertion procedure.In general the implant is in good condition and no damages could be identified.Complained issue (the pfna-ii blade could not be locked after insertion) could not be replicated and/or confirmed as reported problem could not be reproduced.Carried out functional test was passed successfully.The blade could easily be locked and unlocked as intended (see attached pictures).No product problem could be identified.Therefore this complaint is rated as unconfirmed.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 L95 TAN
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7399480
• MDR Text Key: 104460888
• Report Number: 8030965-2018-52793
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819394230
• UDI-Public: (01)07611819394230(17)270301(10)L360623
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.054S
• Device Lot Number: L360623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Date Manufacturer Received: 05/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention