MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L100 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.055S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

Patient ip no reported as (b)(6).Device malfunctioned intra-operatively and was not implanted / explanted.Reporter email address is unknown.Device is not distributed in the united states, but is similar to device marketed in the usa.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.(b)(4).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: during an unknown procedure on (b)(6) 2018, the proximal femoral nail antirotation (pfna) helical blade would not lock.The procedure was completed successfully with a reported delay of fifteen (15) minutes.Patient outcome was okay.Concomitant devices: pfna nail (part: unknown, lot: unknown, quantity: 1).This report is for a pfna-ii blade l100 tan.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.A device history record (dhr) review was conducted for part: 04.027.055s, lot: l847708: manufacturing site: bettlach, release to warehouse date: 13.Apr.2018, expiry date: 01.Apr.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 and visual 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 investigation was conducted.Visual inspection: upon visual inspection of the complaint device it can be seen that the surface is showing signs of usage, and on the tip three (3) of the four (4) lips are showing some damage.Furthermore, the blade we have received back in an open condition.Functional test: during investigation a functional test was performed, the blade passed the functional test.As the blade is fully functional, the complaint is unconfirmed, and no further investigation will be done.Document/specification review: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no document/specification review is needed.Dimensional inspection: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no dimensional inspection is needed.Summary: dhr review showed no issues.There is no particularize information what's happened to this article by customer, unfortunately we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation an application error may have taken place.To prevent such problems, it is necessary to operate according to the technique guide.No product fault could be detected.No corrective action required.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 L100 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7659745
• MDR Text Key: 113299582
• Report Number: 8030965-2018-54791
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819394247
• UDI-Public: (01)07611819394247
• 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: 06/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.055S
• Device Lot Number: L847708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Date Manufacturer Received: 09/03/2018
• Patient Sequence Number: 1
• Treatment: THERAPY DATE: JUNE 8, 2018
• Patient Age: 73 YR