MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH AFN Ø11 R L400 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 477.150S

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There is no patient involvement.It is unknown when metal abrasion occurred.Lot number is unknown.Device was not implanted or 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.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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that pre-operatively, the customer detected metal abrasion inside of the sterile package.The package has not been opened by customer.There is no patient involvement.This report is for an antegrade femoral nail.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records 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.

Manufacturer Narrative

A device history record review was performed for the subject device: part: 477.150s , lot: 9492975 , manufacturing site: (b)(4), release to warehouse date: 29.May 2015 , expiry date: 01.May 2025.The device history record shows this lot of 6 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A product development investigation was performed for the subject device: investigation selection.Investigation site: (b)(4), selected flow: 4.Visual | examples: missing feature or component/peeling coating/corrosion/temperature sensitive indicator.Visual inspection: we have received an afn nail ø11 r l400 tan unpacked.Visual inspection has shown that on the tip the green coating is damaged.All in all the nail is in a good condition without further damage.Document/specification review: not required per selected investigation flow.A as root cause is caused post-manufacturing.Summary: the received condition of the afn nail ø11 r l400 tan is unconcordant with the complaint description and therefore the complaint condition is unconfirmed.This lot of 6 pieces was manufactured in may 2015 according to the specification.The review of the production history revealed that this implant was manufactured according to the specifications.The parts conformed to dimensional / visually specifications at the time of manufacturing and passed inspection requirements.No manufacturing related issues that would have contributed to this complaint were found.Based on that and the condition of the afn nail a product related issue can be excluded.At all above described damages is the anodized layer on the tip worn away, which indicates that they were caused post-manufacturing.We can only assume, that a handling failure of storage lead this occurrence, for example; the packed nail dropped on the floor.Unfortunately, without any packaging material no further investigation possible.A material or manufacturing related issue can be excluded.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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: AFN Ø11 R L400 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7536876
• MDR Text Key: 109011203
• Report Number: 8030965-2018-53928
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819274501
• UDI-Public: (01)07611819274501
• 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: 05/04/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 477.150S
• Device Lot Number: 9492975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 06/08/2018; 07/20/2018
• Supplement Dates FDA Received: 07/03/2018; 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1