MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L90 SST; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 02.027.033S

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Unknown date in (b)(6) 2018.This report is for an unknown pfna blade /unknown lot.Part and lot number are unknown; udi number is unknown.It is unknown if the device was implant/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter phone number and email address were not provided.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 during surgery the blade could not be connected/detached with the impactor.There were no consequences for the patient.This report is for an unknown proximal femoral nail anti-rotation (pfna) blade.This is report 2 of 2 for (b)(4).

Event Description

When the returned devices were being investigated by the manufacturer, it was noted a total of three blades were returned.Clarification was received indicating that all the returned blades had difficulty with connecting.This is report 2 of 4 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.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.H10 additional narrative: h3, h4, h6: a device history record (dhr) review was conducted for part: 02.027.033s , lot: l846665: manufacturing site: bettlach, release to warehouse date: 16.April 2018, expiry date: 01.April 2028: the device history record shows this lot of 40 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.H3, h6: a product investigation was conducted.Visual inspection: the visual inspection of the pfna ¿ blade has shown that the locking screw is too deep inside the blade and therefore the blade could not be locked.Furthermore, the locking screw is complete jammed inside of the outer locking screw.The hexagonal recess of the locking screw is severely damaged.Further investigation has shown that the sleeve near outer locking screw is damaged.Function test: a functional test cannot have performed as a result of the jammed locking screw.Dimensional inspection: not required per selected investigation flow as root cause is use related.Drawing/specification review: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the article, therefore no drawing/specification review is needed.Summary: the returned pfna blade was examined and the complaint condition was able to be confirmed.This lot of 40 pieces was manufactured in april 2018 according to the specification.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities noted; visual and functional checked were performed per 100% after the assembly of the component parts.The investigation has shown that the locking screw is too deep inside the blade and therefore the blade could not be locked.In addition, the hexagonal recess of the locking screw is severely damaged, it is clearly visible that the impactor was not positioned properly.The locking screw is jammed and cannot unscrewed back into end - position anymore.The existing damage, the blade could not be locked and unlocked as required with an impactor.No manufacturing related issues that would have contributed to this complaint were found; this complaint condition is most likely due to inadequate handling.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.

Event Description

This report is for a pfna blade perf l90 sst.

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.Patient ethnicity is unknown.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.

• Brand Name: PFNA BLADE PERF L90 SST
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7638298
• MDR Text Key: 112849367
• Report Number: 8030965-2018-54636
• Device Sequence Number: 1
• Product Code: HSB
• 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,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.027.033S
• Device Lot Number: L846665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Date Manufacturer Received: 08/10/2018
• Patient Sequence Number: 1