MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 14MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.037.459S

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

Patient identifier, weight, and ethnicity not available for reporting.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 reported patient was implanted with a short proximal femoral nail antirotation (pfna) in (b)(6) 2015 for a proximal femur fracture.Following a fall, patient suffered a periprosthetic femur fracture around the pfna.Patient was implanted with a long trochanteric fixation nail advanced (tfna) nail on (b)(6) 2017.Patient suffered another fall and on (b)(6) 2018, x-ray of the left femur revealed the tfna nail was broken in the proximal segment of the nail at the helical blade/nail interface.Patient was returned to surgery on (b)(6) 2018 where the nail, helical blade, and distal locking bolt were removed.Patient underwent a hemiarthroplasty with a long stem hip prosthesis.The helical blade and distal locking bolt were removed intact.Concomitant devices reported: tfna fenestrated helical blade 100mm (04.038.400s, lot h168655, quantity 1), 5.0mm locking screw with t25 stardrive 50mm for im nail (04.005.540s, lot number unknown, quantity 1).This report is for one (1) 14mm 130 degree cannulated tfna nail 380mm left.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.Device history record (dhr) review: manufacturing location: monument; manufacturing date: 18-mar-2016; expiration date: 03-2026; part number: 04.037.459s, lot number: h060288 (sterile) - 14mm/130 deg ti cann tfna 380mm/left- sterile; lot quantity: 6.Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process/inspect dimensional/final ns063066 rev c met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection met all inspection acceptance criteria.Packaging label log was reviewed and determined to be conforming.Scn 12329 by ethicon (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterilization and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component parts reviewed: 04.037.912.4 - wave spring, shim ended for tfna nail assembly bp-55 lot number:7921058; lot quantity: 1,001.Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Material certification and certificate of conformance and smalley quality history card received from smalley dated 05-jun-2015 were reviewed and determined to be conforming.04.037.942.2 - lock prong 130 degree, tfna bp-55 lot number: 9650943; lot quantity: 96 (purchased from synthes gmbh).Work order traveler met all inspection acceptance criteria.04.037.912.3 - tfna lock drive bp-58 lot number: h000772; lot quantity: 80.Work order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.21127 timoagri16.00 bp-80 lot number: 7906100; lot quantity: 1,304 lbs.Certificate of analysis supplied by metalwerks pmd dated 16-dec-2014 was reviewed and determined to be conforming.Lot summary report dated 23-jan-2015 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Investigation summary: the breakage of the nail can be confirmed according to the x-ray image.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.

• Brand Name: 14MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7784232
• MDR Text Key: 117133311
• Report Number: 8030965-2018-55725
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982097637
• UDI-Public: (01)10886982097637
• 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: 07/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.037.459S
• Device Catalogue Number: 04.037.459S
• Device Lot Number: H060288
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR