MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	456.318S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a j&j sales representative.A product investigation was conducted.Visual inspection: the 11/130 dg ti can troch fixatn nl 170-s (part# 456.318s, lot# 98p9990) was returned and received at us cq.Upon visual inspection at cq, the device showed some surface scratches which would not contribute to the complaint condition.No other issues were observed with the returned device.Functional test: a functional assessment was not able to perform on the complaint device since the device was received without the relevant mating devices.As a result, the reported condition for device interaction could not be confirmed.Dimensional inspection: feature: proximal end outer diameter was measured and is conforming per relevant drawing.Feature: proximal end inner diameter was measured and is conforming per relevant drawing.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint was not confirmed since the device was returned by itself without the relevant mating devices so a functional assessment was not able to perform.Only some minor scratches were observed during visual inspection, which would not impact device functionality.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.A device history record (dhr) review was conducted: manufacturing location: monument.Manufacturing date: 05-apr-2021.Expiration date: 28-feb-2030.Part number: 456.318s, 11mm/130 deg ti cann troch fixation nail 170mm-sterile.Lot number: 98p9990 (sterile).Lot quantity: 6.Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final, (b)(4) rev c met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 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: 456.314.3, lock driver tfn.Lot number: 39p7142.Lot quantity: 200.Production order traveler met all inspection acceptance criteria.Inspection sheet, inspect dimensional / final, met all inspection acceptance criteria.Part number: 456.315.2, 130 degree lock prong tfn.Lot number: 47p3830.Lot quantity: 112.Production order traveler met all inspection acceptance criteria.Inspection sheet, inspect 1 / final inspection, met all inspection acceptance criteria.Part number: 21069, tialnbri18.00.Lot number: h172232.Lot quantity: 2,952 lbs.Certificate of tests was reviewed and determined to be conforming.Lot summary report met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.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.
Event or Problem Description
It was reported that on an unknown date, during a procedure, nail would not properly thread onto connecting screw and insertion handle.Surgeon had to open a new nail in order to ensure the nail could be implanted properly.No patient consequence reported.This report is for 1 11mm/130 deg ti cann troch fixation nail 170mm-sterile.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12380165
• Report Number: 2939274-2021-04981
• Device Sequence Number: 14610768
• Product Code: HSB
• UDI-Device Identifier: 10886982226938
• UDI-Public: (01)10886982226938
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2021

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: 456.318S
• Device Catalogue Number: 456.318S
• Device Lot Number: 98P9990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2021
• Initial Report FDA Received Date: 08/27/2021
• Patient Sequence Number: 1