MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH FEMORAL NECK SYSTEM IMPLANT KIT/ LENGTH 100MM STERILE; APPLIANCE, FIXATION, NAIL

Catalog Number 04.168.100S

Device Problem Device-Device Incompatibility (2919)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

This report is for the femoral neck system implant kit (part 04.168.100s, lot l545329, quantity 1).This kit includes: femoral neck screw (part 04.168.500, lot l476195, quantity 1); femoral neck plate (part 04.168.000, lot l468773, quantity 1); femoral neck bolt (part 04.168.300, lot l492347, quantity 1).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.

Event Description

Device report from synthes (b)(6) reports an event as follows: it was reported that on an unknown date, the patient underwent a removal surgery for femoral neck system due to an implant cut out.An x-ray was taken on unknown date and showed an unlocked anti-rotation screw.Removal of the femoral neck system was very difficult thus the surgeon need to use an unknown operance instrument kit during removal.The surgery took an hour and thirty minutes to complete.Patient and procedure outcome was unknown.Concomitant devices reported: locking screw (part/lot unknown, quantity 1).This report captures the intra-operative difficulty removing the construct during the revision procedure.The need for the revision procedure is captured on related complaint (b)(4).This report is for the femoral neck system implant kit.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Concomitant device unknown locking screw was inadvertently reported on initial medwatch report.This is not a concomitant device.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.Additional narrative: event: updated event description.Expiration date.Manufacture site provided for reporting, 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

01/03/2019: updated event description: device report from synthes netherlands reports an event as follows: it was reported that on an unknown date, the patient underwent a removal surgery for femoral neck system due to an implant cut out.An x-ray was taken on unknown date and showed an unlocked antirotation screw.Removal of the femoral neck system was very difficult thus the surgeon needed to use an unknown operace instrument kit during removal.The surgery took an hour and thirty (30) minutes to complete.Patient and procedure outcome was unknown.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.A device history record (dhr) review was conducted: part: 04.168.100s lot: l545329 manufacturing site: grenchen release to warehouse date: 25 aug 2017 expiry date: 01.Aug.2027 the device history record shows this lot of 24 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.Part# 04.168.100s lot l545329 is made from three non-steril component parts: part: 04.168.000 (component part# 60123890) lot: l468773 manufacturing site: grenchen release to warehouse date: 13 july 2017 the device history record shows this lot of 48 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.Part: 04.168.300 (component part# 60123910) lot: l492347 manufacturing site: grenchen release to warehouse date:18 july 2017 the device history record shows this lot of 48 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.Part: 04.168.500 (component part# 60123934) lot: l476195 manufacturing site: grenchen release to warehouse date: 12 aug 2017 the device history record shows this lot of 48 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(s) 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: visual inspection confirmed that the threaded hole of the plate is drilled through.Functional test: a functional test could not be performed due to the damage incurred.Dimensional inspection: the dimensions could not be verified due to the damage incurred, however, dimensions were checked at the time of manufacturing with no issues documented.Document/specification review: the review of the device history record revealed that this implant kit was manufactured in august 2017 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.Summary: during the extraction procedure, the surgeon was not able to remove the ø5.0mm locking screw.An extraction set was used in order to drill the head of the screw away and to release the plate.Based on the received parts the complaint description matches the returned parts and since the threaded hole of the plate and the screw head have been drilled through no further inspection can be performed.No definitive root cause was able to be determined.Multiple factors can lead to technical difficulties during removal of locking screws.These factors include, but are not limited to: wrong torque or angulation of the screw during insertion leading to cold-welding between the plate and the screw thread, or proteins which are forming a bond between the plate and screw thread.Some of these factors are patient specific factors or they depend on the proper care of the surgeon, and can thus not be investigated nor controlled by depuy synthes.Since not all of them can be investigated and excluded from the root cause analysis, no final statement about the cause of such issues during plate removal can be made 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: FEMORAL NECK SYSTEM IMPLANT KIT/ LENGTH 100MM STERILE
• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8200955
• MDR Text Key: 131585248
• Report Number: 8030965-2018-59280
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07612334089748
• UDI-Public: (01)07612334089748
• Combination Product (y/n): N
• PMA/PMN Number: K172872
• 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: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.168.100S
• Device Lot Number: L545329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Date Manufacturer Received: 02/14/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention