MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L90 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.053S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

Additional procode: ktt.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.A device history records review has been requested.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 (b)(4) reports an event in (b)(6) as follows: it was reported that the surgeon used the proximal femoral nail antirotation (pfna) system for a surgery.During the surgery, the pfna blade (90 mm) didn¿t lock inside.The surgeon tried twice but finally gave up as the blade was constantly moving inside the femoral neck.He instead used a 95 mm blade to complete the surgery.The surgery was delayed approximately 40 minutes, and was completed successfully.Patient status is unknown.This complaint is for a pfna-ii blade l90 tan.This is report 1 of 1 for pc-(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.Device history records review was completed for part# 04.027.053s, lot# l679515.Manufacturing location: bettlach, release to warehouse date: dec 05, 2017, expiry date: nov 01, 2027.No non- conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.H3, h6: product development investigation was completed.The complained pfna-ii blade was received in totally unlocked position.The blade could be turned freely.It could be identified that the locking element was inserted too deep into the sleeve, therefore it was no longer possible to connect with the impactor.Several signs of damage / use could be identified which are from contact with the nail while insertion.The device is in good condition.After unscrewing of the locking element from the sleeve by turning them in anti-clock direction, it could be connected to the impactor.The carried out functional test could not reproduce the reported problem.The complained blade could be locked and unlocked as intended.The blade in question is in faultless condition.Therefore, this complaint is classified as unconfirmed.No product problem could be identified.It is recommended to consider pfna-ii surgical technique guide; assemble pfna-ii blade on impactor to prevent any problems.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.

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: e1: reporter facility, address, and phone number are now known.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 L90 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7525210
• MDR Text Key: 108610179
• Report Number: 8030965-2018-53830
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819394223
• UDI-Public: (01)07611819394223
• 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,Followup
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.053S
• Device Lot Number: L679515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Date Manufacturer Received: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR