MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA FENESTRATED HELICAL BLADE 105MM - STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 04.038.405S

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.(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 (b)(6) reports an event as follows: it was reported on an unknown date that there was an adverse outcome using a trochanteric fixation nail advanced (tfna) and spiral blade.The set screw may not have been fully employed to engage the spiral screw.Following the tfna implantation using a helical blade, the patient was discharged and was weight bearing.She subsequently complained of increasing pain and upon further x-rays the helical blade had migrated medially.The tfna and blade were removed and replaced with a new tfna nail, lag screw and lcp proximal femoral hook plate in (b)(6) 2020.Concomitant devices reported: unknown tfna end cap (part # unknown, lot # unknown, quantity 1), unknown locking screw (part # unknown, lot # unknown, quantity unknown).This report is for one (1) tfna fenestrated helical blade 105mm - sterile.This is report 2 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.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

Updated event description: concomitant devices reported: unknown tfna end cap (part # unknown, lot # unknown, quantity 1), unknown locking screw (part # unknown, lot # unknown, quantity unknown).

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.Investigation flow: functional/ damage.Visual inspection: the tfna helical blade perf l105 tan (p/n: 04.038.405s, lot number: h831247, qty# 1) was returned and received at us cq.Upon visual inspection at cq, it is observed that the distal end of the helical blade got deformed.There were few scratches all over the surface of the body.The deformation and scratches might be due to explantation procedure.The device failure/ defect was found.Functional testing: functional testing of the received device was performed at cq.The helical blade was not locking with the received mating device (tfna fem nail 11 le 130° l360 timo15, p/n: 04.037.157s, lot number: h843365) as intended.The lock prong of the tfna is not screwing in and locking the helical blade properly.This might have contributed to the reported device migration condition.The tfna nail is being investigated in pi-(b)(4) under same complaint.The complaint can be replicated with the returned device.Dimensional inspection (calipers: ca122p): dimensional inspection of the received device was performed at cq.Documentation/ specification review: no design issues or discrepancies were found during this investigation.The complaint is confirmed.Investigation conclusion: the complaint is being confirmed for tfna helical blade perf l105 tan (p/n: 04.038.405s, lot number: h831247) as the lock prong of the tfna is not screwing in and locking the helical blade properly.A definitive root cause could not be identified for the reported problem.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot device history review done on august 03, 2020.Part number: 04.038.405s, lot number: h831247, part manufacture date: march 02, 2019, manufacturing location: elmira, part expiration date: february 01, 2029, nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna fenestrated helical blade 105mm was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.The lot quantity of 46 pieces met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the device history record for the raw material revealed no complaint related anomalies.The device history record shows this lot met all requirements at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device history review the lot quantity of 46 pieces met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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.D7: date of explantation is an unknown date in (b)(6) 2020.H4, h6: part: 04.038.405s, lot: h831247, part manufacture date: march 02, 2019, manufacturing location: elmira, part expiration date: february 01, 2029, nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna fenestrated helical blade 105mm was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.The lot quantity of 46 pieces met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the device history record for the raw material revealed no complaint related anomalies.The device history record shows this lot met all requirements at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: TFNA FENESTRATED HELICAL BLADE 105MM - STERILE
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10334182
• MDR Text Key: 205890126
• Report Number: 8030965-2020-05352
• Device Sequence Number: 1
• Product Code: KTT
• 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,Followup
• Report Date: 06/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.405S
• Device Lot Number: H831247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Date Manufacturer Received: 10/28/2020
• Patient Sequence Number: 1
• Treatment: TFNA FEM NAIL Ø11 LE 130° L360 TIMO15; UNK - END CAPS: TFNA; UNK - END CAPS: TFNA; UNK - SCREWS: LOCKING; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention