MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH IMPACTOR F/PFNA BLADE

Catalog Number 356.823

Device Problem Device Difficult to Maintain (3134)

Patient Problem No Patient Involvement (2645)

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

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 review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing 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.

Event Description

It was reported that a patient underwent an unknown surgery on (b)(6) 2018 with a proximal femoral nail antirotation (pfna) to treat a femoral trochanteric fracture.During the procedure, surgeon tried to insert the tip of the impactor into the recess of the blade but could not do this.Surgeon continued to try by changing an angle of insertion, but was not successful.The surgeon used another impactor to complete the procedure.The was procedure was completed with a 30-minute delay without adverse consequence to the patient.This complaint involves two (2) devices.This report is 1 of 2 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.H3, h4, h6: a device history record (dhr) review was conducted: part: 356.823.Lot: 2542857.Manufacturing site: bettlach.Release to warehouse date: 08.Dec.2009.The device history record shows this lot of (b)(4) 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 hexagonal tip of the impactor is partially deformed.Furthermore the device was found in a excessive used condition, such as hammering marks and scratches on the surface.Functional test: a functional test could not be performed, as the relevant feature is deformed in a manner which prevents accurate function test.Based on that fact, the reported complaint description could be confirmed.Dimensional inspection: the relevant feature is deformed in a manner which prevents accurate measurement of the feature.Document/specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition summary: our investigation has shown that the complaint condition is confirmed.Unfortunately we are not able to determine the exact cause of this complaint.The detected wear and tear signs, are most certainly referable to an excessive use of the device.In this case almost 10 years from warehouse release date.The bad condition of the device before surgery did most likely contribute to the reported malfunction.Because of that we would like to draw your attention on page 7 in the leaflet ¿important information¿ with document number (b)(4): check instruments for sound surfaces, and correct adjustment and function.Do not use severely damaged instruments, instruments with unrecognizable markings, corrosion, or blunt cutting surfaces.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: IMPACTOR F/PFNA BLADE
• Type of Device: IMPACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8171717
• MDR Text Key: 130636271
• Report Number: 8030965-2018-59108
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 07611819291317
• UDI-Public: (01)07611819291317
• 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: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 356.823
• Device Lot Number: 2542857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Date Manufacturer Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1