MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA FENESTRATED HELICAL BLADE 85MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.038.385S

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event is an unknown date in 2018.Additional procode: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.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.A device history record review has been requested.(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 that on (b)(6) 2018, patient was implanted with proximal femoral nailing system advance (tfna).Post-operatively, patient complained of pain and x-ray showed that the tfna helical blade was too long.On (b)(6) 2018, revision surgery was performed wherein the helical blade was replaced with tfna screw.There was no surgical delay reported.Patient outcome was good.At two (2) months post-operative, x-rays look normal and patient was encouraged to walk more.Six (6) days later, patient complained of pain.X-ray revealed that the tfna screw had broken.A second revision surgery was performed on (b)(6) 2018.Patient underwent total hip replacement.This report is for a tfna fenestrated helical blade.This is report 1 of 1 for (b)(4) and captures the first revision surgery.The second revision surgery is captured in (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.Complained issue could not be replicated and/or confirmed based on the available information.No pictures and/or x-ray¿s were provided and no material was returned for investigation.Device history lot part number: 04.038.385s lot number: h311751 part manufacturing date: 23 march 2017 manufacturing site: elmira part expiration date: 01 march 2027 a review of the device history record revealed no complaint related anomalies.The device history record shows lot h311751 of tfna helical blades was processed through the normal manufacturing and inspection operations with no rework or nonconformances 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 h077915 met all specifications with no issues documented that would contribute to this complaint condition.A review of the device history record revealed no complaint related anomalies.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.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 85MM - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7948838
• MDR Text Key: 123194307
• Report Number: 8030965-2018-57125
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652569
• UDI-Public: (01)07611819652569
• 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
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.385S
• Device Lot Number: H311751
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 70