MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH INSERT-HANDLE F/A2FN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 03.010.351

Device Problem Failure to Align (2522)

Patient Problem No Code Available (3191)

Event Date 04/30/2018

Event Type  Injury  

Manufacturer Narrative

This information is unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter¿s email address is unknown.Device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review has been requested.(b)(4) used to capture additional medical/surgical intervention required: the complaint indicated that the procedure was not successfully completed.The nail was left inside the patient with the screws outside of the nail holes.The surgeon opted not to attempt correction of the implant.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 malaysia as follows: it was reported that during a surgery on (b)(6) 2018, after the incision was made, surgeon opened the medullary canal with awl under image intensifier.He then inserted a ball tip guide wire and did a reduction at shaft of femur.Surgeon reamed the medullary canal up to 13mm diameter and reamed the proximal third of femur up to 14mm diameter, over the long guide wire through protection sleeve.After measurement of the length, surgeon decided to use expert antegrade femoral (a2fn) nail, 10mm x 380mm, right for this patient.Scrub nurse assembled insertion instruments and surgeon tested the jig and nail before implanting into patient¿s body.After checking everything, the nail was inserted into patient body with hammer.Surgeon tightened the jig again and checked the proximal end of nail by using guide wire.Both yellow three-part trocar sleeve was inserted into the jig.Guide wires were inserted into femoral head through the sleeve under image intensifier.Length of one of the guide wire was measured and the guide wire was removed.Surgeon drilled and inserted the hip screw.After that, he proceeded to the same procedure for another hip screw.Surgeon removed the first screw as it looked like embedded inside the bone.Surgeon decided to reinsert the screw with the addition of washer.Everything checked, and it looked good under image intensifier.Surgeon did two locking distal screws.After removal of all the instrument (jig), surgeon tried to shoot another image intensifier for his documentation for both ap and lateral view.Ap view looked alright.When proceed to the lateral view, he realized that both of the hip screws missed the nail.They are outside the nail holes.He then tried to reinsert the jig into the nail which was inside the bone, however this failed.Sales rep advised to do removal of the implants and reinsert but surgeon refused.The nail was then left inside patient¿s body with 2 pieces of hip screws which missed the nail.Patient outcome is unknown.The surgeon was concerned that the proximal nail end will come out when patient start mobilize since the screws were not holding the nail.However, the surgeon did mention that this patient might not have problems as the fracture was considered a transverse fracture and was already reduced.It is also uncertain whether there will be a removal surgery in the future.Surgeon suspects that the aiming arm was faulty.Concomitant devices reported: guides/sleeves/aiming: sleeve (part # unknown, lot # unknown, quantity 1); drill bit (part # unknown, lot # unknown, quantity 1); screw (part # unknown, lot # unknown, quantity unknown).This report is for an insert-handle f/a2fn.This is report 4 of 4 for (b)(4).

Manufacturer Narrative

Device history record (dhr) review: part no.: 03.010.351; lot no.: l135078; manufacturing location: (b)(4); release to warehouse date: 22.Dec.2016; no nonconformance records (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Investigation summary: no material received for examination, which makes a root cause determination impossible.Also, the received picture of the device does not allow a root cause determination for a misalignment event.The received x-ray pictures show that the hip screw really missed the bores in the nail; the complaint therefore is confirmed.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 malaysia as follows: it was reported that during a surgery on (b)(6) 2018, after incision was made, surgeon opened medullary canal with awl under image intensifier.He then inserted a ball tip guide wire and did a reduction at shaft of femur.Surgeon reamed the medullary canal up to 13mm diameter and reamed the proximal third of femur up to 14mm diameter, over the long guide wire through protection sleeve.After measurement of the length, surgeon decided to use expert antegrade femoral (a2fn) nail, 10mm x 380mm, right for this patient.Scrub nurse assembled insertion instruments and surgeon tested the jig and nail before implanting into patient¿s body.After checking everything, the nail was inserted into patient body with hammer.Surgeon tighten the jig again and check the proximal end of nail by using guide wire.Both yellow three-part trocar sleeve was inserted into the jig.Guide wires were inserted into femoral head through the sleeve under image intensifier.Length of one of the guide wire was measured and the guide wire was removed.Surgeon drilled and inserted the hip screw.After that, he proceeded to the same procedure for another hip screw.Surgeon removed the first screw as it looked like embedded inside the bone.Surgeon decided to reinsert the screw with the addition of washer.Everything checked, and it looked good under image intensifier.Surgeon did two locking distal screws.After removal of all the instrument (jig), surgeon tried to shoot another image intensifier for his documentation for both ap and lateral view.Ap view looked alright.When proceed to the lateral view, he realized that both of the hip screws missed the nail.They are outside the nail holes.He was then tried to reinsert the jig into the nail which was inside the bone, however this failed.Sales rep advised to do removal of the implants and reinsert but surgeon refused.The nail was then left inside patient body with 2 pieces of hip screws which were missed the nail.No information to the patient outcome.The surgeon was concerned that the proximal nail end will come out when patient start mobilize since the screws were not holding the nail.However, the surgeon did mention that this patient might not have problem as the fracture consider transverse fracture and already reduced.It is also uncertain whether there will be a removal surgery in the future.Surgeon suspects that the aiming arm was faulty.Lastly, it was reported that there was a 45 minutes delay.

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.

• Brand Name: INSERT-HANDLE F/A2FN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7548613
• MDR Text Key: 109384712
• Report Number: 8030965-2018-53998
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819326781
• UDI-Public: (01)07611819326781
• 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
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.351
• Device Lot Number: L135078
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR