MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10/130 DEG TI CANN TFNA 170 - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.042S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Patent identifier: (b)(6).Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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: (b)(4), manufacturing date: 05-may-2021, expiration date: 31-mar-2031, part number: 04.037.042s, 10mm/130 deg ti cann tfna 170mm ¿ sterile, lot number: 146p125 (sterile) , lot quantity: 6.Production order traveler met all inspection acceptance criteria.Inspection sheet, in process / inspect dimensional / final, ns071279 rev f met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection, ns067861 rev b met all inspection acceptance criteria.Packaging label log (pll) lppf rev e, lmd rev b was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 19908 supplied by ethicon (b)(4) 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: 86p9633, lot quantity: 197.Two pieces were scrapped in cell at op #50, final inspection, for a discolored surface finish.Production order traveler met all inspection acceptance criteria apart from the two pieces noted.Inspection sheet ns062925 rev e met all inspection acceptance criteria apart from the two pieces noted.Part number: 04.037.912.4, wave spring, shim ended, lot number: 77p1360, lot quantity: 1,000.Production order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, ns062851 rev b met all inspection acceptance criteria.Material certification and certificate of conformance and quality history card supplied by (b)(4) dated 29-jan-2021 were reviewed and determined to be conforming.Part number: 04.037.942.2, lock prong, 130 degree, tfna, lot number: 89p6840, lot quantity: 96.Production order traveler met all inspection acceptance criteria.Part number: 21127, timoagri16.00 bp80 , lot number: 59p0326, lot quantity: 1,868 lbs.Inspection instruction met all inspection acceptance criteria.Certified test report supplied by (b)(4) company dated 16-mar-2020 was reviewed and determined to be conforming.Lot summary report dated 11-jun-2020 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.Device history review 08-dec-2021: dhr reviewed.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 or Problem Description
It was reported that on (b)(6) 2021, the patient is scheduled for tfna revise due to fracture displacement.During extraction the nail was very difficult to connect the extractor.The set screw was back out enough to remove the lag screw and the smith and nephew conical extractor was connected and the nail was successfully removed.It is unknown if the procedure was successfully completed.There was a patient consequence reported.This complaint involves three (3) devices.This report is for (1) 10/130 deg ti cann tfna 170 - sterile.This report is 1 of 3 for (b)(4).Related product complaint: (b)(4).

• Brand Name: 10/130 DEG TI CANN TFNA 170 - STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13113660
• Report Number: 2939274-2021-07268
• Device Sequence Number: 3537622
• Product Code: HSB
• UDI-Device Identifier: 10886982095985
• UDI-Public: (01)10886982095985
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.037.042S
• Device Catalogue Number: 04.037.042S
• Device Lot Number: 146P125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NAIL EXTRACTOR; TFNA FENESTRATED SCREW 95MM - STERILE
• Patient Age: 47 YR
• Patient Sex: Female