MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA FENESTRATED HELICAL BLADE 90MM ¿ STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.038.390S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This report is for one (1) unknown tfna helical blade/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Occupation: reporter is synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 reports an event in (b)(6) as follows: it was reported that on an unknown date, the trochanteric fixation nail-advanced (tfna) extractor was stuck inside the helical blade.It was unknown if there was a procedure or patient involvement.Concomitant device reported: connecting screw (part #: 338.310, lot #: l699672, quantity: 1).This report is for one (1) unknown tfna helical blade.This is report 2 of 2 for complaint (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.A1, b5, d1, d2: additional product code: ktt, d4, d10, g1: physical manufacturer, g5, h4 h3, h6: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.H11: corrected data: b6, b7, d3: legal manufacturer.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 noted the issue was detected during inspection.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Exp date device history part number: 04.038.390s lot number: h165016 part manufacturing date: 07 september 2016 manufacturing site: elmira part expiration date: 01 august 2026 nonconformance noted: n/a a review of the device history record revealed no complaint related anomalies.The device history record shows lot h165016 of tfna helical blades was processed through the normal manufacturing and inspection operations with no rework or non-conformances noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lot 9933344 met all specifications with no issues documented that would contribute to this complaint condition.Device history batch null, device history review review of the device history record(s) showed that there were no issues during the manufacture of this product, which would contribute to this complaint condition investigation summary investigation site: cq zuchwil selected flow: 2.Device interaction/functional visual inspection: the tfna blade and the extraction-instrument for tfna were found jammed as complained.There are no damages visible at the extraction-instrument, while the blade is badly damaged.Functional test: it was not possible to disassemble both devices.Due this evidence, required function test cannot be performed.The complaint condition can be confirmed.Dimensional inspection: the relevant dimension cannot be checked as it is not possible to separate the devices.Document/ specification review: the manufacturing documents were reviewed and no complaint related issues were found.Summary: our investigation has shown that the reported complaint condition could be confirmed as the devices were found jammed together.The damages at the blade indicates that the device was exposed to very high forces and it can be assumed that these forces did finally lead to the jamming between the blade and the extraction instrument.Another factor which could have contributed to the malfunction is, that both devices were probably turned in the wrong direction during the disassembling attempt without considering that both devices have a left hand thread.In this relation the tfna surgical technique can be mentioned where it is stated that the extraction instrument should be rotated clockwise for screw removal.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.

• Brand Name: TFNA FENESTRATED HELICAL BLADE 90MM ¿ STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8130971
• MDR Text Key: 129308791
• Report Number: 8030965-2018-58744
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• 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: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.390S
• Device Lot Number: H165016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Date Manufacturer Received: 02/11/2019
• Patient Sequence Number: 1
• Treatment: SEE EVENT DESCRIPTION