MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA FEM NAIL Ø9 125° L200 TIMO15; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.913S

Device Problem Break (1069)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Device is not distributed in the united states but is similar to device marketed in the usa.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent an open reduction internal fixation surgery for the lateral femoral trochanteric fracture (atypical fracture) with tfna.The patient has been under full weight bearing soon after the surgery to apply dynamization to the bone.On december, the patient had a re-fracture and the nail was broken.On (b)(6), the patient underwent a re-operation in which the nail was replaced by a longer one.The blade used in the initial surgery was reused in the re-operation.The surgeon inserted two screws in the distal area, one of which was inserted in dynamic hole and wrapped around the fracture area with a wire.There was no surgical delay.The patient outcome was unknown.Concomitant device reported: unknown trochanteric femoral nail advanced (tfna) helical blade (part # unknown, lot # unknown, quantity # 1), unknown screws (part # unknown, lot # unknown, quantity # 2), unknown wire (part# unknown, lot# unknown, quantity 1).This is report 1 of 1 for pc-(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.The breakage of the nail could be confirmed according to the received x-rays.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 history lot manufacturing location: monument manufacturing date: nov 08, 2018, expiration date: nov 01, 2028, part number: 04.037.913s, 9mm/125 deg ti cann tfna 200mm- sterile, lot number: h771720 (sterile), lot quantity: 6.Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final ns071261 rev d met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection ns067861 rev b met all inspection acceptance criteria.Packaging label log (pll) lmd rev ac was reviewed and determined to be conforming.Scn 15673 supplied by ethicon (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 04.037.912.2, lock prong, 125 degree tfna, bp55, lot number: l976209, lot quantity: 96.Purchased finished goods traveler met all inspection acceptance criteria.0part number: 04.037.912.4, wave spring, shim ended, bp55, lot number: h613129, lot quantity: 1,000.Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Material certificate and certificate of conformance and quality history card received from smalley dated aug 24, 2018 were reviewed and determined to be conforming.Note: quality history card with recorded sample values documented results for 311 pieces.The sample size was indicated to be 315.Part number: 04.037.912.3, tfna lock drive, bp58, lot number: h766861, lot quantity: 80.Work order traveler met all inspection acceptance criteria.Inspection sheet, met all inspection acceptance criteria.Part number: 21127, timoagri16.00, bp80, lot number: h731048, lot quantity: 2,162 lbs.Certificate of test supplied by ati specialty materials dated aug 24, 2018 was reviewed and determined to be conforming.Lot summary report dated sep 06, 2018 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.Dec 13, 2019: dhr reviewed.This lot met all dimensional, visual, sterility 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.

• Brand Name: TFNA FEM NAIL Ø9 125° L200 TIMO15
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9512847
• MDR Text Key: 189005964
• Report Number: 8030965-2019-71388
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819651715
• UDI-Public: (01)07611819651715
• 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: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.913S
• Device Lot Number: H771720
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/24/2019
• Patient Sequence Number: 1
• Treatment: UNK - GUIDE/COMPRESSION/K-WIRES; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: NAIL DISTAL LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 84