MAUDE Adverse Event Report: SYNTHES GMBH TFNA FEM NAIL 11 125 L200 TIMO15; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.037.113S

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Additional patient identifier: (b)(6).This report is for an unknown tfna nail/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j sales representative.(b)(4).Without a lot number the device history records review could not be completed.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that a patient underwent a revision surgery on (b)(6) 2020 due to a broken trochanetric fixation nail advanced (tfna) nail and delayed healing.The bone had to be fixated with a plate osteosynthesis.It is also reported that the removal of the broken device was difficult and required additional intervention.There was surgical delay of 180 minutes.Initial implant date is reported as (b)(6) 2020.Patient outcome is unknown.No further information provided.Concomitant devices reported: nail head elem: tfna helical blade (part# unknown, lot# unknown, quantity 1); screws: locking: trauma (part# unknown, lot# unknown, quantity unknown).This report is for one (1) unknown tfna nail.This is report 1 of 1 for complaint.

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.Visual inspection: the investigation of the returned tfna nail has shown that the nail is trough the proximal blade hole broken off.In general is the tfna nail in a used condition.Dimensional inspection was performed as below: document/drawing: feature/test/description: outer diameter.Specification: gage 3-01-19788 results "pass." feature/test/description: shaft diameter.Specification: gage 3-01-19788 results "pass." feature/test/description: blade hole.Specification; damage not possible to measurement.Gage 3-01-19788 results "damage not possible to measurement." feature/test/description: inner nail diameter (near blade hole).Specification: gage 3-01-19788 results "pass." the measured dimensions were found to be within the given specifications per the drawings referenced above.Document/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.The examination of the raw-material testing certificate and the manufacturing papers showed no deviations regarding, dimensions, material analysis, strength and structural stability.The values were in compliance with ao/asif specification and with the standard specification of astm f2066 for implants for surgery, ti mo15.The fracture face is homogenous, which indicates material conformity.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device.Summary: the investigation of the returned tfna nail has shown that the nail is trough the proximal blade hole broken off.The exact cause of the breakage cannot be defined as there was just few information provided.Based on the information we received we can only assume that there was a complication during the healing process that caused this problem.The tfna nail could not resist the applied force which finally led to the material overload / fatigue failure.Postoperative activities of the patient and a possible instability of the fracture situation (poor bone density / multifragmentary bone fracture) may have played a certain role, too.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history lot: manufacturing location: monument.Manufacturing date: jan 4, 2020.Expiration date: dec 1, 2029.Part number: 04.037.113s, 11mm/125 deg ti cann tfna 200mm- sterile.Lot number: 32p8827 (sterile).One piece was scrapped in cell at op #20, mill id, due to damage from a chipped tool.Production order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, in-process / inspect dimensional / final, ns500294068 rev a met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection ns067861 rev b met all inspection acceptance criteria.Packaging label log (pll) lmd rev ad was reviewed and determined to be conforming.Scn 17042 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: 04.037.912.3, tfna lock drive.Lot number: 23p4139.Twelve pieces were scrapped in cell at op #10, machine complete, after a tooling breakage.Production order traveler met all inspection acceptance criteria apart from the twelve pieces noted.Inspection sheet, ns062925 rev e met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended.Lot number: 17p1895.Production order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, ns062851 rev b met all inspection acceptance criteria.Material certificate and certificate of conformance and quality history card received from smalley dated 18-oct-2019 were reviewed and determined to be conforming.Part number: 04.037.912.2, lock prong, 125 degree tfna.Lot number: 4l78717.Production order traveler met all inspection acceptance criteria.Part number: 21127, timoagri16.00.Lot number: 17p1413.Inspection instruction met all inspection acceptance criteria.Certified test report supplied by perryman company dated 15-aug-2019 was reviewed and determined to be conforming.Lot summary report dated 11-oct-2019 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.Device history review: 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.

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: tfna scr perf l90 tan (part# 04.038.190, lot# h811489, quantity 1), lockscr ø5 l38 f/nails tan light green (part# 04.005.528, lot# 4l61451, quantity 1).This complaint involves one (1) device.

• Brand Name: TFNA FEM NAIL 11 125 L200 TIMO15
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10810169
• MDR Text Key: 215351734
• Report Number: 8030965-2020-08779
• Device Sequence Number: 1
• Product Code: HSB
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.113S
• Device Lot Number: 32P8827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Date Manufacturer Received: 12/07/2020
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 L38 F/NAILS TAN LIGHT GREEN; TFNA SCR PERF L90 TAN; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: LOCKING; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR